Trial Outcomes & Findings for Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE) (NCT NCT02436668)
NCT ID: NCT02436668
Last Updated: 2020-12-30
Results Overview
PFS is defined as the time from the date of randomization until disease progression per RECIST 1.1 criteria assessed by investigator, or death from any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
430 participants
Primary outcome timeframe
Results at an overall median follow-up of 24.87 months
Results posted on
2020-12-30
Participant Flow
This study was conducted at 75 centers in the United States (US), European Union, and South Korea. The first subject enrolled 08 May 2015 and the last was enrolled on April 19, 2018.
There was a safety run-in of 6 patients; subsequently, 430 total patients were enrolled. Eligible subjects were required to have a confirmed diagnosis of Stage IV pancreatic adenocarcinoma within 6 weeks of randomization evaluable per RECIST 1.1 criteria with at least 1 measurable metastatic lesion. Key exclusion criteria included any previous cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
Participant milestones
| Measure |
Placebo+Gemcitabine+Nab-Paclitaxel
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine
Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
Ibrutinib+Gemcitabine+Nab-paclitaxel
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine
Ibrutinib was administered orally once daily at a starting dose of 560 mg.
Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
211
|
|
Overall Study
COMPLETED
|
212
|
207
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
Baseline characteristics by cohort
| Measure |
Pbo+n-P/G
n=213 Participants
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine
Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
Ibr+n-P/G
n=211 Participants
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine
Ibrutinib- orally once daily at a starting dose of 560 mg.
Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
119 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
94 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Age, Continuous
|
64.0 Years
n=5 Participants
|
64.0 Years
n=7 Participants
|
64.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Results at an overall median follow-up of 24.87 monthsPFS is defined as the time from the date of randomization until disease progression per RECIST 1.1 criteria assessed by investigator, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Ibrutinib+Gemcitabine+Nab-paclitaxel
n=211 Participants
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
Placebo+Gemcitabine+Nab-Paclitaxel
n=213 Participants
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Progression Free Survival (PFS)
|
5.32 Months
Interval 3.75 to 5.49
|
6.01 Months
Interval 5.45 to 7.16
|
PRIMARY outcome
Timeframe: Results at an overall median follow-up of 24.87 monthsOS, is defined as the time from date of randomization until date of death from any cause.
Outcome measures
| Measure |
Ibrutinib+Gemcitabine+Nab-paclitaxel
n=211 Participants
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
Placebo+Gemcitabine+Nab-Paclitaxel
n=213 Participants
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Overall Survival (OS)
|
9.69 Months
Interval 8.57 to 10.41
|
10.78 Months
Interval 8.94 to 11.66
|
SECONDARY outcome
Timeframe: Results at an overall median follow-up of 24.87 monthsPopulation: The safety population included 420 subjects and was used for the analyses of all safety endpoints and included all subjects in the ITT population who received at least 1 dose of study drug (ibrutinib, placebo, nab-paclitaxel, or gemcitabine). The data sets analyzed are summarized in the following table.
This is a measure of percentage of subjects with Treatment Emergent Adverse Events Grade 3 or above collected Up to 30 days after the last participating subject discontinues study drug.
Outcome measures
| Measure |
Ibrutinib+Gemcitabine+Nab-paclitaxel
n=212 Participants
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
Placebo+Gemcitabine+Nab-Paclitaxel
n=208 Participants
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.
Subjects with any TEAE >= Grade 3
|
86.8 percentage of participants
|
85.6 percentage of participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.
Subjects with ibrutinib/pbo-related TEAE >=Grade 3
|
55.7 percentage of participants
|
54.3 percentage of participants
|
SECONDARY outcome
Timeframe: Results at an overall median follow-up of 24.87 monthsORR is defined as the percentage of subjects who achieve a complete response or partial response, based on investigator assessment according to RECIST 1.1.
Outcome measures
| Measure |
Ibrutinib+Gemcitabine+Nab-paclitaxel
n=213 Participants
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
Placebo+Gemcitabine+Nab-Paclitaxel
n=211 Participants
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Overall Response Rate
|
42.3 percentage of Patients
Interval 35.5 to 49.2
|
29.5 percentage of Patients
Interval 23.3 to 36.0
|
SECONDARY outcome
Timeframe: Results at an overall median follow-up of 24.87 monthsPopulation: Clinical benefit response rate was not analyzed due to incomplete data for the analgesic use. Data for subjects who "Achieved a \>=50% reduction in pain intensity", "20-point or greater improvement in KPS (\>=4 consecutive weeks)", "Sustained weight gain (\>=7% increase maintained for \>=4 weeks) not due to fluid accumulation"are reported.
Subject achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card \[MPAC\]) or analgesic consumption, or a 20-point or greater improvement in KPS for a period of at least 4 consecutive weeks, without showing any sustained worsening in other parameters. OR Subject was stable on all of the aforementioned parameters, and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation (Burris 1997).
Outcome measures
| Measure |
Ibrutinib+Gemcitabine+Nab-paclitaxel
n=213 Participants
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
Placebo+Gemcitabine+Nab-Paclitaxel
n=211 Participants
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Clinical Benefit Response
Achieved a >=50% reduction in pain intensity
|
25.8 percentage of patients
|
27.5 percentage of patients
|
|
Clinical Benefit Response
>=20-pt improvement in KPS (>=4 consecutive weeks)
|
1.4 percentage of patients
|
0 percentage of patients
|
|
Clinical Benefit Response
Sustained weight gain (>=7% maintained >4 weeks
|
11.7 percentage of patients
|
5.7 percentage of patients
|
SECONDARY outcome
Timeframe: Results at an overall median follow-up of 24.87 monthsThe CA19-9 response rate is defined as the percentage of subjects with a decline of 20%, 90%, and other thresholds considered clinically meaningful, from baseline. This is a percentage of patients with \> or = 60% reduction from baseline.
Outcome measures
| Measure |
Ibrutinib+Gemcitabine+Nab-paclitaxel
n=213 Participants
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
Placebo+Gemcitabine+Nab-Paclitaxel
n=211 Participants
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Carbohydrate Antigen 19-9 (CA19-9) Response
|
62.9 percentage of patients
Interval 56.0 to 69.4
|
53.6 percentage of patients
Interval 46.6 to 60.4
|
SECONDARY outcome
Timeframe: Results at an overall median follow-up of 24.87 monthsUnit is the month: TUDD1 - the time between random \& 1st occurrence of a decrease in QLQ-C30 score ≥10 pts w/o improvement in QoL score of ≥10 points or any further QoL data due to deterioration. The proportion of subjects who met the "responder" criteria prior to subsequent anticancer therapy initiation. Response defined as achievement of a ≥50% reduction in MPAC visual analog scale which measures pain intensity or analgesic consumption, or a ≥20-point improvement from baseline in KPS sustained for a period of ≥ 4 consecutive weeks without showing any sustained worsening from baseline in any of the other parameters OR Subject stable on all parameters (pain and KPS), \& showed a marked, sustained weight gain (≥7% increase from baseline maintained for ≥4 weeks) not due to fluid accumulation.
Outcome measures
| Measure |
Ibrutinib+Gemcitabine+Nab-paclitaxel
n=213 Participants
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
Placebo+Gemcitabine+Nab-Paclitaxel
n=211 Participants
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
|
6.14 months
Interval 4.86 to 8.21
|
4.21 months
Interval 2.86 to 5.82
|
SECONDARY outcome
Timeframe: Results at an overall median follow-up of 24.87 monthsThe VTE rate is defined as percentage of subjects with Venous thromboembolic events (SMQ) per investigator assessment.
Outcome measures
| Measure |
Ibrutinib+Gemcitabine+Nab-paclitaxel
n=213 Participants
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.
|
Placebo+Gemcitabine+Nab-Paclitaxel
n=211 Participants
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Rate of Venous Thromboembolic Events (VTE)
|
10.8 Percentage of Participants
Interval 7.0 to 15.8
|
8.1 Percentage of Participants
Interval 4.8 to 12.6
|
Adverse Events
Placebo (Plus Nab-paclitaxel and Gemcitabine)
Serious events: 127 serious events
Other events: 211 other events
Deaths: 188 deaths
Ibrutinib (Plus Nab-paclitaxel and Gemcitabine)
Serious events: 112 serious events
Other events: 208 other events
Deaths: 189 deaths
Serious adverse events
| Measure |
Placebo (Plus Nab-paclitaxel and Gemcitabine)
n=212 participants at risk
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine
Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
Ibrutinib (Plus Nab-paclitaxel and Gemcitabine)
n=208 participants at risk
Ibrutinib 560 mg (4 x 140 mg capsules) (or placebo) was administered orally once daily beginning on Day 1 of Cycle 1 of the treatment phase, with the first dose of ibrutinib given no more than 72 hours after randomization
Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
9/212 • Number of events 13 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
3.4%
7/208 • Number of events 7 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
3/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
2.9%
6/208 • Number of events 7 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
4/212 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.9%
4/208 • Number of events 8 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
3/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
4/212 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.4%
3/208 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Cardiac disorders
Left ventricular failure
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Cardiac disorders
Cardiac failure
|
1.4%
3/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Eye disorders
Cataract
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
9/212 • Number of events 10 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
6.7%
14/208 • Number of events 17 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
6/212 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
2.4%
5/208 • Number of events 9 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
11/212 • Number of events 12 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.9%
4/208 • Number of events 7 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.47%
1/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.9%
4/208 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.4%
3/208 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.4%
3/208 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
7/212 • Number of events 7 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.4%
3/208 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Small intestinal ulcer haemorrhage
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Ascites
|
1.4%
3/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.4%
3/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.47%
1/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Retching
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Pyrexia
|
8.0%
17/212 • Number of events 20 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
6.2%
13/208 • Number of events 16 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Asthenia
|
3.3%
7/212 • Number of events 7 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
2.9%
6/208 • Number of events 8 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
General physical health deterioration
|
2.4%
5/212 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.9%
4/208 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Fatigue
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Chest pain
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Chills
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Gait disturbance
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Generalised oedema
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Hyperthermia
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Pain
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Cholangitis
|
1.9%
4/212 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
4.3%
9/208 • Number of events 14 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.4%
3/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Jaundice
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.9%
4/212 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Pneumonia
|
3.8%
8/212 • Number of events 11 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
6.2%
13/208 • Number of events 14 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Cellulitis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.9%
4/208 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Infection
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.9%
4/208 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.9%
4/208 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.9%
4/208 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.4%
3/208 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Escherichia sepsis
|
0.47%
1/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.4%
3/208 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Biliary tract infection
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Neutropenic sepsis
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Biliary sepsis
|
1.4%
3/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Empyema
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.9%
4/212 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Septic shock
|
1.4%
3/212 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Vascular device infection
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Anal abscess
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Bronchitis bacterial
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Device related infection
|
1.9%
4/212 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Diverticulitis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Erysipelas
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Intervertebral discitis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Peritonitis bacterial
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Sepsis
|
1.9%
4/212 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.47%
1/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Blood bilirubin increased
|
0.94%
2/212 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Blood creatinine increased
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Neutrophil count decreased
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Platelet count decreased
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Transaminases increased
|
0.94%
2/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
5/212 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Enzyme abnormality
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.9%
4/208 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
2.8%
6/212 • Number of events 8 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
2.9%
6/208 • Number of events 7 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
2.4%
5/212 • Number of events 8 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
2.4%
5/208 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
1.4%
3/212 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.9%
4/212 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Psychiatric disorders
Depression
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Psychiatric disorders
Suicide attempt
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.4%
3/208 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Renal and urinary disorders
Urinary retention
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
4/212 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Renal and urinary disorders
Azotaemia
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Renal and urinary disorders
Haematuria
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
3/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.4%
3/208 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.94%
2/212 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.96%
2/208 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Embolism
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Arterial haemorrhage
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Venous thrombosis
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Venous thrombosis limb
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Syncope
|
0.94%
2/212 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
1.4%
3/208 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Wernicke's encephalopathy
|
0.00%
0/212 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.48%
1/208 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Cerebral infarction
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Epilepsy
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Psychiatric disorders
Confusional state
|
0.47%
1/212 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
0.00%
0/208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
Other adverse events
| Measure |
Placebo (Plus Nab-paclitaxel and Gemcitabine)
n=212 participants at risk
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine
Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
Ibrutinib (Plus Nab-paclitaxel and Gemcitabine)
n=208 participants at risk
Ibrutinib 560 mg (4 x 140 mg capsules) (or placebo) was administered orally once daily beginning on Day 1 of Cycle 1 of the treatment phase, with the first dose of ibrutinib given no more than 72 hours after randomization
Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
44.8%
95/212 • Number of events 309 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
43.3%
90/208 • Number of events 289 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.9%
55/212 • Number of events 208 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
36.1%
75/208 • Number of events 221 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
39.6%
84/212 • Number of events 328 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
32.7%
68/208 • Number of events 139 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.5%
18/212 • Number of events 61 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
7.2%
15/208 • Number of events 19 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Eye disorders
Vision blurred
|
7.1%
15/212 • Number of events 18 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
8.2%
17/208 • Number of events 20 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
51.4%
109/212 • Number of events 240 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
70.7%
147/208 • Number of events 357 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Nausea
|
50.5%
107/212 • Number of events 242 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
55.8%
116/208 • Number of events 228 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Vomiting
|
40.6%
86/212 • Number of events 184 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
40.9%
85/208 • Number of events 169 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Constipation
|
36.8%
78/212 • Number of events 96 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
32.7%
68/208 • Number of events 91 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.6%
67/212 • Number of events 99 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
30.3%
63/208 • Number of events 94 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.7%
27/212 • Number of events 40 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
18.3%
38/208 • Number of events 64 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
9.9%
21/212 • Number of events 28 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
17.3%
36/208 • Number of events 50 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.9%
21/212 • Number of events 26 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
16.3%
34/208 • Number of events 38 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Ascites
|
11.8%
25/212 • Number of events 35 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
10.1%
21/208 • Number of events 30 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
13/212 • Number of events 13 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
6.2%
13/208 • Number of events 15 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Asthenia
|
43.9%
93/212 • Number of events 283 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
48.1%
100/208 • Number of events 311 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Pyrexia
|
38.7%
82/212 • Number of events 181 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
40.9%
85/208 • Number of events 150 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Fatigue
|
30.7%
65/212 • Number of events 170 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
37.5%
78/208 • Number of events 149 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Oedema peripheral
|
36.3%
77/212 • Number of events 143 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
28.8%
60/208 • Number of events 97 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Mucosal inflammation
|
9.0%
19/212 • Number of events 29 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
11.5%
24/208 • Number of events 36 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
General disorders
Chills
|
7.1%
15/212 • Number of events 21 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
10.1%
21/208 • Number of events 24 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Urinary tract infection
|
7.5%
16/212 • Number of events 25 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
7.7%
16/208 • Number of events 23 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
15/212 • Number of events 17 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
3.4%
7/208 • Number of events 10 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Weight decreased
|
9.9%
21/212 • Number of events 33 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
6.7%
14/208 • Number of events 19 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Platelet count decreased
|
8.0%
17/212 • Number of events 61 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
6.2%
13/208 • Number of events 26 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
25/212 • Number of events 42 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
5.8%
12/208 • Number of events 16 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Neutrophil count decreased
|
9.0%
19/212 • Number of events 48 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
5.3%
11/208 • Number of events 19 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
8.5%
18/212 • Number of events 34 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
3.8%
8/208 • Number of events 12 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.8%
76/212 • Number of events 129 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
40.9%
85/208 • Number of events 135 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.4%
20/212 • Number of events 32 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
12.0%
25/208 • Number of events 37 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.5%
16/212 • Number of events 28 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
8.2%
17/208 • Number of events 24 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.3%
7/212 • Number of events 16 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
5.3%
11/208 • Number of events 14 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
12/212 • Number of events 14 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
2.4%
5/208 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.5%
35/212 • Number of events 58 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
13.5%
28/208 • Number of events 36 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
25/212 • Number of events 38 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
12.0%
25/208 • Number of events 31 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.3%
26/212 • Number of events 30 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
8.2%
17/208 • Number of events 20 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.3%
24/212 • Number of events 31 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
8.2%
17/208 • Number of events 24 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.2%
11/212 • Number of events 13 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
5.3%
11/208 • Number of events 13 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.2%
11/212 • Number of events 15 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
2.4%
5/208 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
29.7%
63/212 • Number of events 153 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
33.2%
69/208 • Number of events 171 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Paraesthesia
|
9.4%
20/212 • Number of events 42 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
13.0%
27/208 • Number of events 79 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Headache
|
9.4%
20/212 • Number of events 24 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
10.1%
21/208 • Number of events 25 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Dizziness
|
9.4%
20/212 • Number of events 22 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
9.6%
20/208 • Number of events 22 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Dysgeusia
|
12.3%
26/212 • Number of events 33 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
9.1%
19/208 • Number of events 24 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.6%
14/212 • Number of events 28 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
7.2%
15/208 • Number of events 33 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Neurotoxicity
|
8.5%
18/212 • Number of events 47 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
6.7%
14/208 • Number of events 40 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.2%
11/212 • Number of events 23 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
6.2%
13/208 • Number of events 30 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Psychiatric disorders
Insomnia
|
16.0%
34/212 • Number of events 36 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
9.6%
20/208 • Number of events 23 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.9%
21/212 • Number of events 27 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
17.3%
36/208 • Number of events 41 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.3%
43/212 • Number of events 64 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
12.0%
25/208 • Number of events 34 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.8%
42/212 • Number of events 47 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
7.2%
15/208 • Number of events 19 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.5%
16/212 • Number of events 22 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
4.3%
9/208 • Number of events 14 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.7%
12/212 • Number of events 16 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
3.4%
7/208 • Number of events 7 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
41.0%
87/212 • Number of events 119 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
43.3%
90/208 • Number of events 130 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.2%
28/212 • Number of events 42 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
11.1%
23/208 • Number of events 28 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
6/212 • Number of events 7 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
6.7%
14/208 • Number of events 16 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.1%
15/212 • Number of events 21 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
5.8%
12/208 • Number of events 16 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
25/212 • Number of events 36 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
3.8%
8/208 • Number of events 8 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Hypotension
|
6.1%
13/212 • Number of events 15 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
5.8%
12/208 • Number of events 15 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
|
Vascular disorders
Hypertension
|
6.1%
13/212 • Number of events 34 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
5.3%
11/208 • Number of events 33 • From first dose of study drug up to 30 days after the last dose of study drug
There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 1. Institution/Investigator will not publish without Sponsor prior review and approval 2. Institution/Investigator will not publish until the earlier of (i) results of study are submitted for publication (ii) notification that submission of the multicenter results are no longer planned (iii) 18 months after study termination.
- Publication restrictions are in place
Restriction type: OTHER