Trial Outcomes & Findings for M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC) (NCT NCT03840915)
NCT ID: NCT03840915
Last Updated: 2023-08-21
Results Overview
DLT was defined as Adverse Events(AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to(\>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting \>= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for \>= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (\<) 1,000/Cubic Millimeter(mm3) with a temperature of \> 38.3 degree Celsius (°C); grade 4 is defined as ANC \< 1,000/mm3 with a temperature of \> 38.3°C, with life-threatening consequences; Thrombocytopenia \< 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events \>= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay(\> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Day 1 Week 1 up to Week 3
Results posted on
2023-08-21
Participant Flow
A total of 127 participants were screened out of which 70 participants who received study intervention.
Participant milestones
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
9
|
9
|
12
|
|
Overall Study
Safety Analysis Set
|
40
|
9
|
9
|
12
|
|
Overall Study
Full Analysis Set
|
40
|
9
|
9
|
12
|
|
Overall Study
Dose-Limiting Toxicity Analysis Set
|
8
|
8
|
8
|
11
|
|
Overall Study
COMPLETED
|
40
|
9
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=40 Participants
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=12 Participants
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
64 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
61 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
60 Years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
62 Years
STANDARD_DEVIATION 9.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Unknown or Not Reported
|
25 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race-Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race-White
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race-Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race-Not Collected
|
25 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 Week 1 up to Week 3Population: Dose-Limiting Toxicity Analysis (DLT) Set included all participants who received at least 90 percent (%) of the bintrafusp alfa infusion and all other planned study administrations during the DLT observation period of 3 weeks and who did not discontinue the study for other reasons than DLT during the first cycle, or who experienced at least one DLT.
DLT was defined as Adverse Events(AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to(\>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting \>= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for \>= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (\<) 1,000/Cubic Millimeter(mm3) with a temperature of \> 38.3 degree Celsius (°C); grade 4 is defined as ANC \< 1,000/mm3 with a temperature of \> 38.3°C, with life-threatening consequences; Thrombocytopenia \< 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events \>= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay(\> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity.
Outcome measures
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=8 Participants
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=8 Participants
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=8 Participants
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=11 Participants
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Time from first treatment assessed up to approximately 26 monthsPopulation: The safety analysis set (SAF) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies).
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs.
Outcome measures
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=40 Participants
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=12 Participants
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
40 Participants
|
9 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
31 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Time from first treatment assessed up to approximately 26 monthsPopulation: The full analysis set (FAS) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies).
Percentage of participants with confirmed objective response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator.
Outcome measures
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=40 Participants
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=12 Participants
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator (IRC)
|
45.0 Percentage of Participants
Interval 29.3 to 61.5
|
66.7 Percentage of Participants
Interval 29.9 to 92.5
|
44.4 Percentage of Participants
Interval 13.7 to 78.8
|
16.7 Percentage of Participants
Interval 2.1 to 48.4
|
SECONDARY outcome
Timeframe: Time from first administration of study drug until the first documentation of PD or death, assessed up to approximately 26 monthsPopulation: The full analysis set (FAS) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies)
PFS was defined as the time from first administration of study intervention until date of the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Kaplan-Meier estimates was used to calculate PFS.
Outcome measures
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=40 Participants
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=12 Participants
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
|
5.0 months
Interval 0.0 to 14.3
|
4.1 months
Interval 1.2 to 17.7
|
5.4 months
Interval 1.4 to 19.6
|
2.6 months
Interval 1.3 to 10.4
|
SECONDARY outcome
Timeframe: Time from first treatment assessed up to approximately 26 monthsPopulation: The full analysis set (FAS) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies)
OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=40 Participants
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=12 Participants
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
11.4 months
Interval 6.4 to 15.1
|
11.8 months
Interval 1.9 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not be derived.
|
NA months
Interval 5.7 to
Due to small number of events, estimate (Median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not be derived.
|
16.5 months
Interval 3.0 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not be derived.
|
SECONDARY outcome
Timeframe: Time from first documentation of a confirmed objective response to PD or death due to any cause (assessed up to approximately 26 months)Population: The full analysis set (FAS) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies)
DOR was defined for participants with confirmed response, as the time from first documentation of confirmed objective response (Complete Response \[CR\] or Partial Response \[PR\]) according to RECIST 1.1 to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Results were calculated based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=40 Participants
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=12 Participants
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
9.6 months
Interval 3.7 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not be derived.
|
NA months
Interval 2.8 to
Due to small number of events, estimate (Median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not be derived.
|
10.5 months
Interval 2.8 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not be derived.
|
3.4 months
Interval 3.0 to 3.8
|
SECONDARY outcome
Timeframe: Predose, Day 22, Day 43, Day 64 and Day 85Population: In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected.
Ceoi was the observed concentration at the end of the infusion period. This was taken directly from the observed Bintrafusp Alfa concentration-time data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, Day 22, Day 43, Day 64 and Day 85Population: In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected.
Ctrough was the serum concentration observed immediately before next dosing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, Day 22, Day 43, Day 64 and Day 85Population: In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected.
The area under the concentration-time curve (AUC) from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, Day 22, Day 43, Day 64 and Day 85Population: In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected.
The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from terminal first order (elimination) rate constant determination. AUC0-inf= AUC0-tlast +Clast pred/ terminal first order (elimination) rate constant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, Day 22, Day 43, Day 64 and Day 85Population: In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, Day 22, Day 43, Day 64 and Day 85Population: In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected.
The time to reach the maximum observed concentration collected during a dosing interval. Tmax was obtained directly from the concentration versus time curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, Day 22, Day 43, Day 64 and Day 85Population: In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected.
Elimination half-life determined as 0.693/terminal first order (elimination) rate constant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from first treatment assessed up to approximately 26 monthsPopulation: Immunogenicity Analysis Set included all participants who have received at least of 1 dose of bintrafusp alfa + chemotherapy and had at least 1 valid antidrug antibody result.
Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.
Outcome measures
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=38 Participants
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=9 Participants
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=8 Participants
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=12 Participants
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Number of Participants With Positive Antidrug Antibodies (ADA)
|
9 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
Serious events: 31 serious events
Other events: 40 other events
Deaths: 23 deaths
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
Serious events: 5 serious events
Other events: 9 other events
Deaths: 4 deaths
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
Serious events: 6 serious events
Other events: 9 other events
Deaths: 4 deaths
Cohort D: Bintrafusp Alfa + Docetaxel
Serious events: 9 serious events
Other events: 12 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=40 participants at risk
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=9 participants at risk
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=9 participants at risk
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=12 participants at risk
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
2/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Bicytopenia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Myelosuppression
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
25.0%
3/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Acute myocardial infarction
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Cardiac failure congestive
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Myocarditis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Endocrine disorders
Adrenal insufficiency
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Colitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Enteritis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.5%
1/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Asthenia
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Death
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Disease progression
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
General physical health deterioration
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
COVID-19 pneumonia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Endocarditis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Haematoma infection
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Haemophilus sepsis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Spinal cord infection
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Staphylococcal sepsis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Yersinia bacteraemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.5%
1/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Nephritis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Renal failure
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
2.5%
1/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
25.0%
3/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Haematoma
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Haemodynamic instability
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
2.5%
1/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Peripheral ischaemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
Other adverse events
| Measure |
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed
n=40 participants at risk
Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin 75 mg/ m\^2 (per meter square) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed at a dose of 500 mg/ m\^2 over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days) until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel
n=9 participants at risk
Participants received 2400 mg Bintrafusp alfa along with Carboplatin at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel at as dose of 100 mg/m\^2 over 30 to 60 minutes(Nab- paclitaxel was administered on Day 1, 8, and 15), and Paclitaxel at a dose of 200 mg/m2 over 3 hours every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine
n=9 participants at risk
Participants received 2400 mg Bintrafusp alfa along with Cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes or Carboplatin at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine at a dose of 1250 mg/m\^2 over 30 to 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
Cohort D: Bintrafusp Alfa + Docetaxel
n=12 participants at risk
Participants received 2400 mg Bintrafusp alfa along with Docetaxel at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
20/40 • Number of events 28 • Time from first treatment assessed up to approximately 26 months
|
66.7%
6/9 • Number of events 12 • Time from first treatment assessed up to approximately 26 months
|
100.0%
9/9 • Number of events 9 • Time from first treatment assessed up to approximately 26 months
|
75.0%
9/12 • Number of events 9 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Myelosuppression
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
5/40 • Number of events 7 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
55.6%
5/9 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.5%
7/40 • Number of events 13 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
44.4%
4/9 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Angina pectoris
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Cardiac failure
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Mitral valve incompetence
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Myocarditis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Tachycardia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Cardiac disorders
Tricuspid valve incompetence
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Ear and labyrinth disorders
Ear discomfort
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Ear and labyrinth disorders
Tinnitus
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
4/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
4/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Endocrine disorders
Immune-mediated hyperthyroidism
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Eye disorders
Blepharitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Eye disorders
Blepharospasm
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Eye disorders
Diplopia
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Eye disorders
Dry eye
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Eye disorders
Lacrimation increased
|
5.0%
2/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Eye disorders
Visual impairment
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Eye disorders
Xerophthalmia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Colitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Constipation
|
17.5%
7/40 • Number of events 10 • Time from first treatment assessed up to approximately 26 months
|
66.7%
6/9 • Number of events 10 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Diarrhoea
|
32.5%
13/40 • Number of events 15 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
50.0%
6/12 • Number of events 10 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
33.3%
4/12 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Duodenitis
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
4/40 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Enteritis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Haematochezia
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Melaena
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Nausea
|
52.5%
21/40 • Number of events 29 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
66.7%
6/9 • Number of events 11 • Time from first treatment assessed up to approximately 26 months
|
41.7%
5/12 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Oesophageal pain
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Oesophagitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Oral pain
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.0%
2/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
5/40 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Stomatitis haemorrhagic
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Subileus
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Tongue dry
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
7/40 • Number of events 12 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
41.7%
5/12 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Asthenia
|
37.5%
15/40 • Number of events 20 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
44.4%
4/9 • Number of events 10 • Time from first treatment assessed up to approximately 26 months
|
58.3%
7/12 • Number of events 10 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Axillary pain
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Catheter site inflammation
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Catheter site oedema
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Chest pain
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
25.0%
3/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Chills
|
5.0%
2/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Face oedema
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Fatigue
|
17.5%
7/40 • Number of events 9 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Gait disturbance
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
General physical health deterioration
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Hernia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Hyperthermia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Malaise
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Mucosal inflammation
|
10.0%
4/40 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Oedema peripheral
|
15.0%
6/40 • Number of events 8 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
25.0%
3/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Pain
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Pyrexia
|
27.5%
11/40 • Number of events 16 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
33.3%
4/12 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
|
General disorders
Xerosis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Hepatobiliary disorders
Cholestasis
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
5.0%
2/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Hepatobiliary disorders
Hepatitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Bronchitis
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Candida infection
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Conjunctivitis
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Device related infection
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Folliculitis
|
5.0%
2/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Fungal skin infection
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Furuncle
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Gastroenteritis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Gingivitis
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Herpes simplex
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Hordeolum
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Oral candidiasis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Oral fungal infection
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Paronychia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Periodontitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Pneumonia
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Rash pustular
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Rhinitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Skin infection
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Tooth infection
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Urinary tract infection
|
10.0%
4/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Wound infection
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Infections and infestations
Yersinia bacteraemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Eye contusion
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Head injury
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Amylase increased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
4/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Blood creatinine increased
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Blood urea increased
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Blood uric acid increased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Eosinophil count increased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Gastric pH decreased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Haematocrit decreased
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Lipase increased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Neutrophil count decreased
|
5.0%
2/40 • Number of events 7 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Neutrophil count increased
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Platelet count decreased
|
7.5%
3/40 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
SARS-CoV-2 test positive
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Sputum abnormal
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Weight decreased
|
12.5%
5/40 • Number of events 9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
Weight increased
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Investigations
White blood cell count decreased
|
7.5%
3/40 • Number of events 12 • Time from first treatment assessed up to approximately 26 months
|
44.4%
4/9 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Cell death
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.5%
7/40 • Number of events 9 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
44.4%
4/9 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
50.0%
6/12 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
25.0%
3/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.0%
6/40 • Number of events 9 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.5%
3/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.5%
3/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
4/40 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
25.0%
3/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
1/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
33.3%
4/12 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 11 • Time from first treatment assessed up to approximately 26 months
|
44.4%
4/9 • Number of events 15 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Ataxia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Dysgeusia
|
10.0%
4/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Headache
|
10.0%
4/40 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Motor dysfunction
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Paraesthesia
|
7.5%
3/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Sciatica
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Taste disorder
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Nervous system disorders
Tremor
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Psychiatric disorders
Agitation
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Psychiatric disorders
Anxiety
|
10.0%
4/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Psychiatric disorders
Hallucination
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Psychiatric disorders
Insomnia
|
15.0%
6/40 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Psychiatric disorders
Pica
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Psychiatric disorders
Sleep disorder
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Haematuria
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Nephritis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Renal failure
|
10.0%
4/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Renal impairment
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Reproductive system and breast disorders
Penile erosion
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
6/40 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.0%
6/40 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
41.7%
5/12 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
10/40 • Number of events 14 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
44.4%
4/9 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
33.3%
4/12 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
33.3%
4/12 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
4/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
2.5%
1/40 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
5/40 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.5%
1/40 • Number of events 5 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 8 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
4/40 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
7.5%
3/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Papule
|
5.0%
2/40 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
15/40 • Number of events 22 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
66.7%
6/9 • Number of events 11 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.5%
7/40 • Number of events 9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
16.7%
2/12 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 2 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.0%
2/40 • Number of events 4 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 6 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 12 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion inflammation
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
22.2%
2/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Artery dissection
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Hypotension
|
17.5%
7/40 • Number of events 8 • Time from first treatment assessed up to approximately 26 months
|
33.3%
3/9 • Number of events 3 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
11.1%
1/9 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Phlebitis
|
0.00%
0/40 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
8.3%
1/12 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
|
Vascular disorders
Venous thrombosis
|
2.5%
1/40 • Number of events 1 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/9 • Time from first treatment assessed up to approximately 26 months
|
0.00%
0/12 • Time from first treatment assessed up to approximately 26 months
|
Additional Information
Communication Center
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place