Trial Outcomes & Findings for Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting (NCT NCT02004262)
NCT ID: NCT02004262
Last Updated: 2018-06-04
Results Overview
OS was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs), with censoring at the date when 138 deaths were reached in the Primary Cohort in the FAS. Subjects without documentation of death at the time of final analysis were censored as of the date the subject was last known to be alive on/prior to the primary analysis data cut.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
303 participants
Primary outcome timeframe
Subjects were followed from date of randomization to the date of death by any cause, whichever came first, assessed up to 32 months. Analysis conducted when 138 deaths reached in the Primary Cohort in the FAS.
Results posted on
2018-06-04
Participant Flow
This study enrolled patients with previously treated metastatic pancreatic adenocarcinoma from 21 medical centers in the United States and Canada. The last patient completed the study in August 2016.
Participants screened over a 21-day period.
Participant milestones
| Measure |
Primary Cohort: Cy/GVAX + CRS-207
* 200 mg per square meter (mg/m\^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units \[CFU\]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
* The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting.
|
Primary Cohort: CRS-207
* CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.
* The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting.
|
Primary Cohort: Chemotherapy
* Investigator's choice of one of the following: gemcitabine (1000 mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m\^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg\^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m\^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.
* The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting.
|
2nd-line Cohort: Cy/GVAX + CRS-207
* 200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
* The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting.
|
2nd-line Cohort: CRS-207
* CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.
* The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting.
|
2nd-line Cohort: Chemotherapy
* Investigator's choice of one of the following: gemcitabine (1000 mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m\^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg\^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m\^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.
* The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
68
|
72
|
29
|
31
|
30
|
|
Overall Study
Treated
|
68
|
58
|
43
|
26
|
29
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
73
|
68
|
72
|
29
|
31
|
30
|
Reasons for withdrawal
| Measure |
Primary Cohort: Cy/GVAX + CRS-207
* 200 mg per square meter (mg/m\^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units \[CFU\]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
* The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting.
|
Primary Cohort: CRS-207
* CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.
* The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting.
|
Primary Cohort: Chemotherapy
* Investigator's choice of one of the following: gemcitabine (1000 mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m\^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg\^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m\^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.
* The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting.
|
2nd-line Cohort: Cy/GVAX + CRS-207
* 200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
* The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting.
|
2nd-line Cohort: CRS-207
* CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.
* The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting.
|
2nd-line Cohort: Chemotherapy
* Investigator's choice of one of the following: gemcitabine (1000 mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m\^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg\^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m\^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.
* The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
67
|
64
|
66
|
28
|
29
|
22
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
4
|
0
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
4
|
3
|
2
|
1
|
1
|
5
|
Baseline Characteristics
Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
Baseline characteristics by cohort
| Measure |
Primary Cohort: Cy/GVAX + CRS-207
n=68 Participants
|
Primary Cohort: CRS-207
n=58 Participants
|
Primary Cohort: Chemotherapy
n=43 Participants
|
2nd-line Cohort: Cy/GVAX + CRS-207
n=26 Participants
|
2nd-line Cohort: CRS-207
n=29 Participants
|
2nd-line Cohort: Chemotherapy
n=11 Participants
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 7.96 • n=99 Participants
|
63.2 years
STANDARD_DEVIATION 8.92 • n=107 Participants
|
64.0 years
STANDARD_DEVIATION 10.85 • n=206 Participants
|
63.9 years
STANDARD_DEVIATION 11.83 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 9.43 • n=31 Participants
|
66.6 years
STANDARD_DEVIATION 10.86 • n=30 Participants
|
63.7 years
STANDARD_DEVIATION 9.48 • n=3 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
116 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
119 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Subjects were followed from date of randomization to the date of death by any cause, whichever came first, assessed up to 32 months. Analysis conducted when 138 deaths reached in the Primary Cohort in the FAS.Population: Analysis based on subjects in the Primary Cohort in the intent-to-treat (ITT) set. The ITT set is the analysis population that included all randomized study subjects.
OS was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs), with censoring at the date when 138 deaths were reached in the Primary Cohort in the FAS. Subjects without documentation of death at the time of final analysis were censored as of the date the subject was last known to be alive on/prior to the primary analysis data cut.
Outcome measures
| Measure |
Primary Cohort: Cy/GVAX + CRS-207
n=73 Participants
|
Primary Cohort: CRS-207
n=68 Participants
|
Primary Cohort: Chemotherapy
n=72 Participants
|
|---|---|---|---|
|
Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set)
|
3.8 months
Interval 2.9 to 5.3
|
5.4 months
Interval 4.2 to 6.9
|
4.6 months
Interval 4.2 to 5.8
|
PRIMARY outcome
Timeframe: Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.Population: Analysis based on subjects in the Primary Cohort in the FAS.
For all treated subjects, OS was calculated using KM methods with 95% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis data cut.
Outcome measures
| Measure |
Primary Cohort: Cy/GVAX + CRS-207
n=68 Participants
|
Primary Cohort: CRS-207
n=58 Participants
|
Primary Cohort: Chemotherapy
n=43 Participants
|
|---|---|---|---|
|
Primary Cohort: OS (All Data, FAS)
|
4.2 months
Interval 3.0 to 5.4
|
5.2 months
Interval 4.2 to 6.3
|
4.7 months
Interval 3.8 to 6.0
|
PRIMARY outcome
Timeframe: Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.Population: Analysis based on subjects in the 2nd-line Cohort in the FAS.
For all treated subjects, OS was calculated using KM methods with 70% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis cut. 70% CIs were selected to provide an 80% probability to rule out differences in median survival less than -2.4 months between the 2nd-line Cohort: Chemotherapy arm and the 2nd-line Cohort: Cy/GVAX + CRS-207 and 2nd-line Cohort: CRS-207 arms, based upon the assumptions made in the statistical analysis plan (SAP).
Outcome measures
| Measure |
Primary Cohort: Cy/GVAX + CRS-207
n=26 Participants
|
Primary Cohort: CRS-207
n=29 Participants
|
Primary Cohort: Chemotherapy
n=11 Participants
|
|---|---|---|---|
|
2nd-line Cohort: OS (All Data, FAS)
|
4.6 months
Interval 3.9 to 6.0
|
4.0 months
Interval 3.4 to 6.7
|
6.9 months
Interval 4.2 to 12.3
|
SECONDARY outcome
Timeframe: From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.Population: Analysis conducted for the FAS of each study arm.
Safety was assessed based upon the number of adverse events (AEs) that occurred in the FAS of each treatment arm, including serious AEs and total AEs. Total AEs included both serious and non-serious AEs.
Outcome measures
| Measure |
Primary Cohort: Cy/GVAX + CRS-207
n=94 Participants
|
Primary Cohort: CRS-207
n=87 Participants
|
Primary Cohort: Chemotherapy
n=54 Participants
|
|---|---|---|---|
|
Number of Participants With Adverse Events in Each Treatment Arm Treatment Regimen
Serious AEs
|
44 Participants
|
32 Participants
|
15 Participants
|
|
Number of Participants With Adverse Events in Each Treatment Arm Treatment Regimen
Total AEs
|
94 Participants
|
87 Participants
|
52 Participants
|
Adverse Events
Pooled Cohort: Cy/GVAX + CRS-207
Serious events: 44 serious events
Other events: 94 other events
Deaths: 88 deaths
Pooled Cohort: CRS-207
Serious events: 32 serious events
Other events: 87 other events
Deaths: 82 deaths
Pooled Cohort: Chemotherapy
Serious events: 15 serious events
Other events: 51 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Pooled Cohort: Cy/GVAX + CRS-207
n=94 participants at risk
* 200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
* Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 Cy/GVAX + CRS-207 treatment were combined to form the Pooled Cohort.
|
Pooled Cohort: CRS-207
n=87 participants at risk
* CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.
* Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 CRS-207 treatment were combined to form the Pooled Cohort.
|
Pooled Cohort: Chemotherapy
n=54 participants at risk
* Investigator's choice of one of the following: gemcitabine (1000 mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m\^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg\^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m\^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.
* Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 chemotherapy treatment were combined to form the Pooled Cohort.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
4.3%
4/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
2.3%
2/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
2.3%
2/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
2/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Ileus
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
2.3%
2/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.1%
2/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Ascites
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Disease progression
|
13.8%
13/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.7%
5/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Pyrexia
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Death
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Asthenia
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Device dislocation
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Oedema peripheral
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Pain
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
3.2%
3/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Hepatobiliary disorders
Cholangitis
|
2.1%
2/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Sepsis
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Influenza
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Klebsiella sepsis
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Lung infection
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.1%
2/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Memory impairment
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Spinal cord compression
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Syncope
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
4/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
2.3%
2/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.1%
2/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.4%
3/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Haemorrhage
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Superior vena cava syndrome
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Psychiatric disorders
Mental status changes
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Psychiatric disorders
Confusional state
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Psychiatric disorders
Hallucination
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic complication
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
2/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Weight decreased
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
2.1%
2/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Renal and urinary disorders
Renal failure acute
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
Other adverse events
| Measure |
Pooled Cohort: Cy/GVAX + CRS-207
n=94 participants at risk
* 200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
* Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 Cy/GVAX + CRS-207 treatment were combined to form the Pooled Cohort.
|
Pooled Cohort: CRS-207
n=87 participants at risk
* CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.
* Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 CRS-207 treatment were combined to form the Pooled Cohort.
|
Pooled Cohort: Chemotherapy
n=54 participants at risk
* Investigator's choice of one of the following: gemcitabine (1000 mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m\^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg\^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m\^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.
* Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 chemotherapy treatment were combined to form the Pooled Cohort.
|
|---|---|---|---|
|
General disorders
Chills
|
62.8%
59/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
93.1%
81/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
9.3%
5/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Pyrexia
|
54.3%
51/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
66.7%
58/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
16.7%
9/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Fatigue
|
53.2%
50/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
43.7%
38/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
48.1%
26/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Vaccination site erythema
|
81.9%
77/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Vaccination site induration
|
56.4%
53/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Vaccination site pain
|
56.4%
53/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Vaccination site oedema
|
54.3%
51/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Vaccination site pruritus
|
52.1%
49/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Vaccination site bruising
|
26.6%
25/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Oedema peripheral
|
16.0%
15/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
6.9%
6/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Disease progression
|
13.8%
13/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.7%
5/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Pain
|
8.5%
8/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
8.0%
7/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Asthenia
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.4%
3/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
General disorders
Vaccination site vesicles
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
44.7%
42/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
50.6%
44/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
53.7%
29/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
34.0%
32/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
36.8%
32/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
24.1%
13/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.9%
30/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
37.9%
33/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
22.2%
12/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
26.6%
25/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
24.1%
21/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
18.5%
10/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
12/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
20.7%
18/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
37.0%
20/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.5%
8/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
7.4%
4/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.6%
9/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
8.5%
8/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.7%
5/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Ascites
|
8.5%
8/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.4%
3/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
3/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.7%
5/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
2.3%
2/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.5%
24/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
18.4%
16/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
35.2%
19/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
7/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
11.5%
10/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
13.0%
7/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.8%
13/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
8.0%
7/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.6%
3/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.5%
8/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
6.9%
6/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
9.3%
5/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.5%
8/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
10.3%
9/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
6.9%
6/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.4%
3/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
18.1%
17/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
23.0%
20/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Blood alkaline phosphatase increased
|
19.1%
18/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
14.9%
13/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
12.8%
12/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
18.4%
16/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Weight decreased
|
10.6%
10/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
6.9%
6/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.6%
3/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Blood bilirubin increased
|
8.5%
8/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.4%
3/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Blood albumin decreased
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
8.0%
7/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Lymphocyte count decreased
|
7.4%
7/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Blood creatinine increased
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
Blood sodium decreased
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Investigations
International normalised ratio increased
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.2%
19/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
20.7%
18/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
16.7%
9/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.8%
12/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
11.5%
10/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
7.4%
4/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
2.3%
2/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.6%
3/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Hypotension
|
19.1%
18/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
20.7%
18/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Hypertension
|
10.6%
10/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
14.9%
13/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.6%
3/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.1%
18/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
14.9%
13/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.6%
3/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
7/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
12.6%
11/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
8.0%
7/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.7%
5/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Headache
|
19.1%
18/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
21.8%
19/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Dizziness
|
7.4%
7/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
11.5%
10/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.6%
3/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.2%
3/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
7.4%
4/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.7%
11/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.7%
5/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
13.0%
7/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
20.4%
11/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.5%
8/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.1%
1/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.2%
3/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
7.4%
4/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
8/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
8.0%
7/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
11.1%
6/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.4%
3/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.4%
6/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.4%
3/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
2/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.7%
5/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.6%
3/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Cardiac disorders
Tachycardia
|
13.8%
13/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
17.2%
15/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
3.2%
3/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
6.9%
6/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Psychiatric disorders
Insomnia
|
9.6%
9/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.7%
5/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Psychiatric disorders
Confusional state
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
4.6%
4/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.7%
2/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Psychiatric disorders
Anxiety
|
2.1%
2/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.7%
5/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.6%
3/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
3/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.4%
3/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
7.4%
4/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
3/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
0.00%
0/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
5.6%
3/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
5.3%
5/94 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
3.4%
3/87 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
1.9%
1/54 • From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
Adverse events reported for the FAS study population. Study data were not compiled for other (not including serious) adverse events as an individual category. Therefore, the reported data in the "Other (Not Including Serious) Adverse Events" section includes all adverse events reported in the study and occurring with a 5% or greater frequency, including both serious and non-serious adverse events.
|
Additional Information
Corporate Communications
Aduro Biotech, Inc.
Phone: 510-848-4400
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60