Trial Outcomes & Findings for Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers (NCT NCT02034110)
NCT ID: NCT02034110
Last Updated: 2023-08-21
Results Overview
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
206 participants
Primary outcome timeframe
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
Results posted on
2023-08-21
Participant Flow
The study was conducted in 41 centers in 14 countries worldwide.
Subjects were enrolled into cohorts based on the type of histology. For each histology, up to 25 patients were planned to be enrolled. A cohort could be closed or stopped early (prior to capping at 25 patients) for futility or efficacy. An uncapped expansion cohort was planned when a particular cohort was stopped early for efficacy.
Participant milestones
| Measure |
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
43
|
1
|
13
|
45
|
3
|
55
|
10
|
|
Overall Study
Primary Analysis Cohort
|
15
|
18
|
1
|
13
|
24
|
3
|
24
|
10
|
|
Overall Study
Expansion Cohort
|
21
|
25
|
0
|
0
|
21
|
0
|
31
|
0
|
|
Overall Study
COMPLETED
|
24
|
34
|
1
|
4
|
28
|
3
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
0
|
9
|
17
|
0
|
47
|
1
|
Reasons for withdrawal
| Measure |
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
0
|
3
|
7
|
0
|
3
|
1
|
|
Overall Study
Study closed by sponsor
|
6
|
2
|
0
|
6
|
7
|
0
|
42
|
0
|
Baseline Characteristics
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
Baseline characteristics by cohort
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=36 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
n=43 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
n=1 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
n=13 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
n=45 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
n=3 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
n=55 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
n=10 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.6 Years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
57.0 Years
STANDARD_DEVIATION 11.88 • n=7 Participants
|
77.0 Years
STANDARD_DEVIATION NA • n=5 Participants
|
33.1 Years
STANDARD_DEVIATION 11.51 • n=4 Participants
|
41.9 Years
STANDARD_DEVIATION 14.70 • n=21 Participants
|
58.3 Years
STANDARD_DEVIATION 3.21 • n=8 Participants
|
64.8 Years
STANDARD_DEVIATION 10.77 • n=8 Participants
|
66.9 Years
STANDARD_DEVIATION 6.89 • n=24 Participants
|
57.1 Years
STANDARD_DEVIATION 16.40 • n=42 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
90 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
116 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European heritage
|
17 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
157 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
ECOG Performance Status
Grade 0
|
4 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
72 Participants
n=42 Participants
|
|
ECOG Performance Status
Grade 1
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
118 Participants
n=42 Participants
|
|
ECOG Performance Status
Grade 2
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=36 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort
Investigator assessment @ up to 78 months
|
56 Percentage of Participants
Interval 38.1 to 72.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort
Investigator assessment @ up to 92 months
|
56 Percentage of Participants
Interval 38.1 to 72.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort
Independent radiology review @ up to 78 months
|
53 Percentage of Participants
Interval 35.5 to 69.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort
Independent radiology review @ up to 92 months
|
53 Percentage of Participants
Interval 35.5 to 69.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=43 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort
Investigator assessment @ up to 78 months
|
53 Percentage of Participants
Interval 37.7 to 68.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort
Investigator assessment @ up to 92 months
|
53 Percentage of Participants
Interval 37.7 to 68.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort
Independent radiology review @ up to 78 months
|
47 Percentage of Participants
Interval 31.2 to 62.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort
Independent radiology review @ up to 92 months
|
47 Percentage of Participants
Interval 31.2 to 62.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=1 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort
Investigator assessment @ 78 months
|
0 Percentage of Participants
95% Confidence Interval not determined as there are an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort
Investigator assessment @ 92 months
|
0 Percentage of Participants
95% Confidence Interval not determined as there are an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=3 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Investigator assessment @ up to 78 months
|
67 Percentage of Participants
Interval 9.4 to 99.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Investigator assessment @ up to 92 months
|
67 Percentage of Participants
Interval 9.4 to 99.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (response assessment criteria (CR, PR, and minor response \[MR\]) WHO Grade 1 and 2 Glioma) by investigator assessment as defined by response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=13 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Investigator assessment/Response rate @ up to 92 months
|
69 Percentage of Participants
Interval 38.6 to 90.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Independent radiology review/Response rate @ up to 78 months
|
69 Percentage of Participants
Interval 38.6 to 90.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Independent radiology review/Response rate @ up to 92 months
|
62 Percentage of Participants
Interval 31.6 to 86.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Investigator assessment/Response rate @ up to 78 months
|
69 Percentage of Participants
Interval 38.6 to 90.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (updated response assessment criteria (CR, PR) WHO Grade 3 and 4 Glioma) by investigator assessment as defined by modified response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=45 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Investigator assessment @ up to 78 months
|
33 Percentage of Participants
Interval 20.0 to 49.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Investigator assessment @ up to 92 months
|
33 Percentage of Participants
Interval 20.0 to 49.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Independent radiology review @ up to 78 months
|
31 Percentage of Participants
Interval 18.2 to 46.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Independent radiology review @ up to 92 months
|
31 Percentage of Participants
Interval 18.2 to 46.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Overall Response Rate (ORR) was defined as the percentage of participants with CR +/- minimal residual disease \[MRD\], PR by investigator assessment as defined by the Consensus Resolution Criteria adapted from the National Comprehensive Cancer Network (NCCN) guidelines. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=55 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in the Hairy Cell Leukemia (HCL) Cohort
Investigator assessment @ up to 78 months
|
89 Percentage of Participants
Interval 77.8 to 95.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Hairy Cell Leukemia (HCL) Cohort
Investigator assessment @ up to 92 months
|
89 Percentage of Participants
Interval 77.8 to 95.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort
Overall Response Rate (ORR) was defined as the percentage of participants with stringent complete response (sCR), CR, PR, very good partial response (VGPR) by investigator assessment as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=10 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in the Multiple Myeloma (MM) Cohort
Investigator assessment @ up to 92 months
|
50 Percentage of Participants
Interval 18.7 to 81.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (ORR) in the Multiple Myeloma (MM) Cohort
Investigator assessment @ up to 78 months
|
50 Percentage of Participants
Interval 18.7 to 81.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis.
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=20 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) in the Anaplastic Thyroid Cancer (ATC) Cohort
Investigator assessment
|
62.4 Weeks
Interval 32.1 to
Not estimable due to insufficient events observed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response (DoR) in the Anaplastic Thyroid Cancer (ATC) Cohort
Independent radiology review
|
59.1 Weeks
Interval 16.6 to 171.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis.
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=23 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) in the Biliary Tract Cancer (BTC) Cohort
Investigator assessment
|
38.9 Weeks
Interval 24.3 to 59.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response (DoR) in the Biliary Tract Cancer (BTC) Cohort
Independent radiology review
|
45.4 Weeks
Interval 20.1 to 64.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=2 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Investigator assessment
|
33.4 Weeks
Not estimable due to insufficient events observed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response (DoR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Independent radiology review
|
32.8 Weeks
Interval 32.1 to
Not estimable due to insufficient events observed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=9 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Investigator assessment
|
NA Weeks
Interval 24.1 to
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response (DoR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Independent radiology review
|
84.3 Weeks
Interval 16.4 to
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis.
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=15 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Investigator assessment
|
135.7 Weeks
Interval 32.0 to 192.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response (DoR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Independent radiology review
|
59.3 Weeks
Interval 20.1 to 116.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis.
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=49 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) in the Hairy Cell Leukemia (HCL) Cohort
|
NA Weeks
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=5 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) in the Multiple Myeloma (MM) Cohort
|
48.1 Weeks
Interval 24.3 to
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=36 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) in the Anaplastic Thyroid Cancer (ATC) Cohort
Investigator assessment
|
29.1 Weeks
Interval 20.3 to 59.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Progression Free Survival (PFS) in the Anaplastic Thyroid Cancer (ATC) Cohort
Independent radiology review
|
24.1 Weeks
Interval 16.1 to 56.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=43 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) in the Biliary Tract Cancer (BTC) Cohort
Investigator assessment
|
39.0 Weeks
Interval 24.1 to 41.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Progression Free Survival (PFS) in the Biliary Tract Cancer (BTC) Cohort
Independent radiology review
|
32.6 Weeks
Interval 23.6 to 56.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort.
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=3 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Investigator assessment
|
41.3 Weeks
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Progression Free Survival (PFS) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Independent radiology review
|
40.1 Weeks
Interval 4.1 to
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort.
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=13 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Investigator assessment
|
NA Weeks
Interval 32.1 to
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Progression Free Survival (PFS) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Independent radiology review
|
40.1 Weeks
Interval 20.3 to 143.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=45 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Investigator assessment
|
24.0 Weeks
Interval 8.0 to 59.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Progression Free Survival (PFS) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Independent radiology review
|
19.7 Weeks
Interval 8.0 to 32.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=55 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) in the Hairy Cell Leukemia (HCL) Cohort
|
NA Weeks
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - primary analysis cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=10 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) in the Multiple Myeloma (MM) Cohort
|
27.5 Weeks
Interval 10.0 to 55.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=36 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in the Anaplastic Thyroid Cancer (ATC) Cohort
|
62.9 Weeks
Interval 29.6 to 100.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=43 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in the Biliary Tract Cancer (BTC) Cohort
|
58.9 Weeks
Interval 45.4 to 76.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=3 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
|
94.6 Weeks
Interval 14.9 to
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=13 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
|
NA Weeks
Interval 50.4 to
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined.
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=45 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
|
76.4 Weeks
Interval 41.1 to 139.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary and expansion cohort combined
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=55 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in the Hairy Cell Leukemia (HCL) Cohort
|
NA Weeks
Not estimable due to insufficient events observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: ITT/Evaluable population - Primary analysis cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=10 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in the Multiple Myeloma (MM) Cohort
|
147.3 Weeks
Interval 12.4 to 194.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study treatment start date till 30 days safety follow-up, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)Population: All-treated Subjects (ATS) population - Primary and expansion cohort combined
The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs) through the monitoring of relevant clinical and laboratory safety parameters.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=36 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
n=43 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
n=1 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
n=13 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
n=45 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
n=3 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
n=55 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
n=10 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AE
|
36 Participants
|
43 Participants
|
1 Participants
|
12 Participants
|
42 Participants
|
3 Participants
|
55 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs related to study treatment
|
27 Participants
|
42 Participants
|
1 Participants
|
12 Participants
|
37 Participants
|
3 Participants
|
52 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to permanent discontinuation of any study treatment
|
6 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
13 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to dose reduction
|
17 Participants
|
15 Participants
|
1 Participants
|
4 Participants
|
18 Participants
|
2 Participants
|
29 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to dose interruption/delay
|
19 Participants
|
24 Participants
|
1 Participants
|
6 Participants
|
18 Participants
|
2 Participants
|
40 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any SAE
|
20 Participants
|
17 Participants
|
1 Participants
|
3 Participants
|
16 Participants
|
0 Participants
|
32 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs)
SAEs related to study treatment
|
7 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
19 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)
Fatal SAEs
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: On-treatment deaths: Up to 85 months. Post-treatment survival follow-up deaths: Up to 92 months.Population: All-treated Subjects (ATS) population - Primary and expansion cohort combined
On-treatment deaths were collected from first dose of study medication to 30 days after study drug discontinuation, for a maximum duration of 85 months. Post-treatment survival follow-up deaths were collected from day 31 after last dose of first dose of study medication, up to 92 months. All deaths refer to the sum of on-treatment deaths and post-treatment survival follow-up deaths.
Outcome measures
| Measure |
Anaplastic Thyroid Cancer (ATC)
n=36 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC)
n=43 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST)
n=1 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG)
n=13 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG)
n=45 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI)
n=3 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL)
n=55 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM)
n=10 Participants
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
|---|---|---|---|---|---|---|---|---|
|
All Collected Deaths
On-treatment deaths
|
6 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
All Collected Deaths
Post-treatment survival follow-up deaths
|
18 Participants
|
28 Participants
|
1 Participants
|
3 Participants
|
26 Participants
|
3 Participants
|
4 Participants
|
8 Participants
|
|
All Collected Deaths
All deaths
|
24 Participants
|
34 Participants
|
1 Participants
|
4 Participants
|
28 Participants
|
3 Participants
|
8 Participants
|
9 Participants
|
Adverse Events
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Serious events: 20 serious events
Other events: 36 other events
Deaths: 6 deaths
Biliary Tract Cancer (BTC) (On-Treatment)
Serious events: 17 serious events
Other events: 43 other events
Deaths: 6 deaths
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Serious events: 16 serious events
Other events: 42 other events
Deaths: 2 deaths
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Hairy Cell Leukemia (HCL) (On-Treatment)
Serious events: 32 serious events
Other events: 55 other events
Deaths: 4 deaths
Multiple Myeloma (MM) (On-Treatment)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 28 deaths
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 26 deaths
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
n=36 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC) (On-Treatment)
n=43 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
n=1 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
n=13 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
n=45 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
n=3 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL) (On-Treatment)
n=55 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM) (On-Treatment)
n=10 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Amnesia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Dysphagia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Haematochezia
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Stress cardiomyopathy
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Diplopia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Chills
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Fat necrosis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Fatigue
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
General physical health deterioration
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Pyrexia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.9%
9/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
18.2%
10/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Cervicitis human papilloma virus
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Clostridium difficile infection
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Device related infection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Diverticulitis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Gastroenteritis pseudomonas
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Infection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Influenza
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Parotitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Pelvic infection
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Pneumonia
|
22.2%
8/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Pneumonia aspiration
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Pneumonia necrotising
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Staphylococcal infection
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Viral infection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Wound infection
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Ejection fraction decreased
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Neutrophil count decreased
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Transaminases increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Aphasia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Dizziness
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Facial nerve disorder
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Headache
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Paralysis recurrent laryngeal nerve
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Product Issues
Device failure
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Hallucination
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Haematuria
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haematoma
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Aortic thrombosis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
Other adverse events
| Measure |
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
n=36 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Biliary Tract Cancer (BTC) (On-Treatment)
n=43 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
n=1 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
n=13 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
n=45 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
n=3 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Hairy Cell Leukemia (HCL) (On-Treatment)
n=55 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Multiple Myeloma (MM) (On-Treatment)
n=10 participants at risk
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
|
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Neutrophil count increased
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
12.7%
7/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
12/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.3%
10/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.8%
4/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
9/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
18.2%
10/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.6%
7/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.9%
6/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
40.0%
4/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.3%
7/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
12.7%
7/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Sinus bradycardia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.6%
13/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Tachycardia
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.9%
6/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Endocrine disorders
Hypothyroidism
|
11.1%
4/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Cataract
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Diplopia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Dry eye
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.1%
5/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Eye pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Iritis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Macular oedema
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Papilloedema
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Photophobia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Saccadic eye movement
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Uveitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Vision blurred
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
25.5%
14/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Visual impairment
|
11.1%
4/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
12.7%
7/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.6%
5/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
66.7%
2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
21.8%
12/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.3%
7/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
8/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.9%
9/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.8%
4/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
17.8%
8/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
40.0%
22/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.4%
7/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
32.6%
14/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.8%
4/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
34.5%
19/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Dry mouth
|
13.9%
5/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
18.6%
8/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.5%
8/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.1%
5/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
6/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.9%
6/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
12/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
41.9%
18/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
53.8%
7/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
31.1%
14/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
49.1%
27/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
50.0%
5/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Oral pain
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Toothache
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
19.4%
7/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
34.9%
15/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.8%
4/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
24.4%
11/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.6%
13/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Asthenia
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.3%
7/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Chills
|
22.2%
8/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
27.9%
12/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
54.5%
30/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Fatigue
|
36.1%
13/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
32.6%
14/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
61.5%
8/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
42.2%
19/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
52.7%
29/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Feeling cold
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Gait disturbance
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Influenza like illness
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
12.7%
7/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Injection site reaction
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Malaise
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.9%
6/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Mucosal inflammation
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Nodule
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Non-cardiac chest pain
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Oedema
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Oedema peripheral
|
13.9%
5/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
49.1%
27/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Pain
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Peripheral swelling
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Pyrexia
|
47.2%
17/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
58.1%
25/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
61.5%
8/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
24.4%
11/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
66.7%
2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
74.5%
41/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Thirst
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Xerosis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.1%
5/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Conjunctivitis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.5%
8/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Folliculitis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Fungal infection
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Infection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
38.5%
5/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.6%
7/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Oral candidiasis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Paronychia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Pneumonia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.9%
6/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.1%
5/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Sinusitis
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Skin candida
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Skin infection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Tooth infection
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.5%
8/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
27.3%
15/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
13.3%
6/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.5%
8/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
18.2%
10/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.4%
9/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Radiation associated pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
4/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.3%
7/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
9/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
32.7%
18/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Aspartate aminotransferase increased
|
13.9%
5/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
25.6%
11/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.8%
4/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
9/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
38.2%
21/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
6/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.9%
9/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
29.1%
16/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood creatinine increased
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.6%
5/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.6%
13/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood glucose increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood oestrogen decreased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood urea increased
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Ejection fraction decreased
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
12.7%
7/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Electrocardiogram QT prolonged
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.1%
5/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
27.9%
12/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Lipase increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Liver function test increased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Neutrophil count decreased
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
17.8%
8/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
18.6%
8/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.6%
7/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
45.5%
25/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
34.5%
19/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.6%
13/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Dizziness
|
19.4%
7/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
36.4%
20/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.1%
5/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Headache
|
22.2%
8/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.3%
10/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
61.5%
8/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
40.0%
18/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
38.2%
21/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Hypoaesthesia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Palatal palsy
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Paraesthesia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.4%
9/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Polyneuropathy
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Tremor
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
VIth nerve disorder
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Anxiety
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Depression
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.1%
5/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Insomnia
|
13.9%
5/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.0%
6/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.4%
9/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Sleep disorder
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Haematuria
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
18.2%
10/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Pollakiuria
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.4%
9/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Proteinuria
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
4/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.3%
10/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
17.8%
8/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
54.5%
30/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
8/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.3%
7/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.6%
13/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
12.7%
7/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
11.1%
4/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
36.4%
20/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
11/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
16.4%
9/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
12.7%
7/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.9%
6/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
40.0%
22/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
4/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
38.5%
5/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.9%
17/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.6%
5/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.6%
5/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.1%
5/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.5%
8/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
66.7%
2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
4/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.6%
5/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
46.2%
6/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
18.2%
10/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.8%
10/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
27.9%
12/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.8%
4/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
26.7%
12/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
11/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
34.5%
19/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Flushing
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Hot flush
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Hypertension
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.0%
6/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.5%
8/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Hypotension
|
13.9%
5/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.5%
8/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Platelet count decreased
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.6%
5/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Urine output decreased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Weight decreased
|
11.1%
4/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Weight increased
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
33.3%
1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
White blood cell count decreased
|
13.9%
5/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.3%
10/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
13.3%
6/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
12/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.3%
10/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
13.3%
6/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
12.7%
7/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
30.0%
3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.3%
3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.9%
5/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
18.6%
8/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
45.5%
25/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
19.4%
7/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.9%
6/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.9%
5/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
4/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.4%
2/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.6%
5/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
19.4%
7/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.6%
5/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
11/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.9%
5/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
14.0%
6/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
53.8%
7/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.6%
7/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
38.2%
21/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
20.0%
2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.1%
5/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
6/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.1%
3/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
6.7%
3/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
23.6%
13/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
11.1%
5/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.9%
6/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.2%
1/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.8%
1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
8.9%
4/45 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
3.6%
2/55 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER