Trial Outcomes & Findings for Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects (NCT NCT00865709)
NCT ID: NCT00865709
Last Updated: 2014-12-11
Results Overview
Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
198 participants
Primary outcome timeframe
From randomization of the first subject until 23 months later, assessed every 8 weeks.
Results posted on
2014-12-11
Participant Flow
Participant milestones
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
|---|---|---|
|
Treatment
STARTED
|
97
|
101
|
|
Treatment
Received Treatment
|
97
|
101
|
|
Treatment
COMPLETED
|
67
|
83
|
|
Treatment
NOT COMPLETED
|
30
|
18
|
|
Active Follow-up
STARTED
|
25
|
16
|
|
Active Follow-up
COMPLETED
|
17
|
15
|
|
Active Follow-up
NOT COMPLETED
|
8
|
1
|
|
Long Term Follow-up
STARTED
|
70
|
82
|
|
Long Term Follow-up
COMPLETED
|
24
|
33
|
|
Long Term Follow-up
NOT COMPLETED
|
46
|
49
|
Reasons for withdrawal
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
|---|---|---|
|
Treatment
Adverse Event
|
9
|
6
|
|
Treatment
Withdrawal by Subject
|
10
|
7
|
|
Treatment
Physician Decision
|
3
|
2
|
|
Treatment
Surgery
|
8
|
3
|
Baseline Characteristics
Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects
Baseline characteristics by cohort
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
n=97 Participants
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
n=101 Participants
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Number of metastatic sites by Principal Investigator
<3
|
71 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Number of metastatic sites by Principal Investigator
>=3
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
KRAS
Mutant
|
33 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
KRAS
Wild-Type
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
KRAS
Missing
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
3 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
54 participants
n=5 Participants
|
52 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
0=Fully active without restriction
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
1= Restricted in physically strenuous activity
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
2= Ambulatory, capable of all selfcare
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
3= Capable of limited selfcare
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
4= Completely disabled
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
5= Dead
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Stage of Disease at study entry (TNM Classification, Stage IV)
|
97 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Time since initial diagnosis
|
9.8 Months
STANDARD_DEVIATION 16.2 • n=5 Participants
|
9.2 Months
STANDARD_DEVIATION 16.9 • n=7 Participants
|
9.5 Months
STANDARD_DEVIATION 16.6 • n=5 Participants
|
|
Liver metastases by Principal Investigator
Yes
|
79 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Liver metastases by Principal Investigator
No
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization of the first subject until 23 months later, assessed every 8 weeks.Population: The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).
Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
n=97 Participants
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
n=101 Participants
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
9.1 Months
Interval 7.6 to 9.7
|
8.7 Months
Interval 7.4 to 9.5
|
SECONDARY outcome
Timeframe: From randomization of the first subject until 33 months later.Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
n=97 Participants
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
n=101 Participants
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
|---|---|---|
|
Overall Survival (OS)
|
535 days
Interval 437.0 to 613.0
|
552 days
Interval 453.0 to 651.0
|
SECONDARY outcome
Timeframe: From randomization of the first subject until 23 months later, assessed every 8 weeks.Population: The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).
Time to progression (TTP) was defined as the time from date of randomization to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
n=97 Participants
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
n=101 Participants
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
|---|---|---|
|
Time to Progression (TTP)
|
9.2 Months
Interval 7.8 to 11.0
|
9.0 Months
Interval 7.6 to 10.4
|
SECONDARY outcome
Timeframe: From randomization of the first subject until 23 months later, assessed every 8 weeks.Population: The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).
Overall response of a subject was defined as the best tumor response (Complete Response (CR) or Partial Response (PR)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
n=97 Participants
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
n=101 Participants
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
|---|---|---|
|
Overall Response
|
45 participants
|
61 participants
|
SECONDARY outcome
Timeframe: From randomization of the first subject until 23 months later, assessed every 8 weeksPopulation: Duration of response was the time from the first documented CR or PR until the first documented PD or death (if before progression). Only responders (CR or PR) were included in the analysis
Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) was first documented or to the date of death, whichever occurred first according to Response Evaluation Criteria in Solid Tumors (RECIST). Subjects still having CR or PR and alive at the time of analysis were censored at their last date of tumor evaluation. CR was defined as disappearance of tumor lesions, PR as a decrease of at least 30% and PD as an increase of at least 20% in the sum of tumor lesions sizes.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
n=45 Participants
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
n=61 Participants
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
|---|---|---|
|
Duration of Response
|
7.5 months
Interval 5.7 to 9.4
|
6.7 months
Interval 5.5 to 8.1
|
Adverse Events
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
Serious events: 30 serious events
Other events: 96 other events
Deaths: 0 deaths
Matching Placebo + mFOLFOX6
Serious events: 27 serious events
Other events: 99 other events
Deaths: 0 deaths
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (OS Update)
Serious events: 33 serious events
Other events: 96 other events
Deaths: 0 deaths
Matching Placebo + mFOLFOX6 (OS Update)
Serious events: 30 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
n=97 participants at risk
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
n=101 participants at risk
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (OS Update)
n=97 participants at risk
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6 (OS Update)
n=101 participants at risk
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.0%
3/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Duodenal perforation
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Enteritis
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Device related infection
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Cellulitis
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Diabetic foot infection
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Osteomyelitis
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Proctitis bacterial
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Pyrexia
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Chest discomfort
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Device breakage
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Disease progression
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Mucosal inflammation
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Renal and urinary disorders
Renal failure
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Renal and urinary disorders
Renal failure acute
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.0%
2/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Cardiac disorders
Myocardial ischaemia
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Cerebral ischaemia
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Dizziness
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Sciatica
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Vascular disorders
Axillary vein thrombosis
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Vascular disorders
Circulatory collapse
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Vascular disorders
Thrombosis
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.0%
3/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.0%
3/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Hepatobiliary disorders
Hepatic failure
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Blood amylase increased
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Blood creatinine increased
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Eye disorders
Retinal vein thrombosis
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Psychiatric disorders
Delirium
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metasteses to central nervous system
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
Other adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
n=97 participants at risk
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6
n=101 participants at risk
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (OS Update)
n=97 participants at risk
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
|
Matching Placebo + mFOLFOX6 (OS Update)
n=101 participants at risk
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.5%
49/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
38.6%
39/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
50.5%
49/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
38.6%
39/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Nausea
|
37.1%
36/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
48.5%
49/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
37.1%
36/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
48.5%
49/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Vomiting
|
24.7%
24/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
19.8%
20/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
24.7%
24/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
21.8%
22/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Abdominal pain
|
15.5%
15/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
22.8%
23/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
16.5%
16/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
22.8%
23/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Constipation
|
12.4%
12/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
20.8%
21/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
12.4%
12/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
20.8%
21/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Stomatitis
|
22.7%
22/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
4.0%
4/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
22.7%
22/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.2%
8/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
8.2%
8/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.9%
7/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
3/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.1%
3/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
4.0%
4/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.0%
3/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Abdominal distension
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.9%
7/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Proctalgia
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.7%
22/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
24.8%
25/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
22.7%
22/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
24.8%
25/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Dysaesthesia
|
16.5%
16/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
20.8%
21/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
16.5%
16/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
20.8%
21/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Neurotoxicity
|
19.6%
19/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
12.9%
13/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
19.6%
19/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
12.9%
13/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Paraesthesia
|
10.3%
10/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
19.8%
20/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
10.3%
10/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
18.8%
19/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Neuropathy peripheral
|
13.4%
13/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
8.9%
9/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
13.4%
13/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Dysgeusia
|
12.4%
12/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
12.4%
12/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Hypoaesthesia
|
9.3%
9/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
8.9%
9/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.3%
9/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
8.9%
9/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Dizziness
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Headache
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.0%
3/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
4.0%
4/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Nervous system disorders
Lethargy
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Asthenia
|
32.0%
31/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
23.8%
24/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
32.0%
31/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
23.8%
24/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Fatigue
|
22.7%
22/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
23.8%
24/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
22.7%
22/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
23.8%
24/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Mucosal inflammation
|
21.6%
21/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
15.8%
16/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
21.6%
21/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
15.8%
16/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Pyrexia
|
10.3%
10/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
10.9%
11/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
10.3%
10/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
10.9%
11/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
General disorders
Oedema peripheral
|
3.1%
3/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.1%
3/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Blood and lymphatic system disorders
Neutropenia
|
61.9%
60/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
38.6%
39/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
61.9%
60/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
38.6%
39/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.6%
18/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
24.8%
25/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
18.6%
18/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
24.8%
25/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Blood and lymphatic system disorders
Anaemia
|
23.7%
23/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
14.9%
15/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
23.7%
23/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
14.9%
15/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.3%
11/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.9%
7/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
11.3%
11/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.9%
7/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
53.6%
52/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
10.9%
11/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
53.6%
52/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
10.9%
11/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.7%
23/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
24.7%
24/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.7%
23/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
23.7%
23/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.2%
7/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
7.9%
8/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
7.2%
7/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
7.9%
8/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.3%
11/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
4.0%
4/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
12.4%
12/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
4.0%
4/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.0%
3/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.0%
3/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.3%
9/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.3%
9/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
9/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
7.9%
8/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.3%
9/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
7.9%
8/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia pharynx
|
3.1%
3/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.1%
3/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Blood amylase increased
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Platelet count decreased
|
3.1%
3/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
7.9%
8/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.1%
3/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
7.9%
8/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Aspartate aminotransferase increased
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.9%
7/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Lipase increased
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
4.0%
4/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
4.0%
4/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Alanine aminotransferase increased
|
4.1%
4/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
4.1%
4/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Weight decreased
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.99%
1/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.4%
13/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
15.8%
16/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
13.4%
13/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
15.8%
16/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.2%
5/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.9%
6/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Vascular disorders
Hypertension
|
20.6%
20/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
20.6%
20/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
9.9%
10/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Vascular disorders
Phlebitis
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.9%
7/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.9%
7/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.9%
7/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.9%
7/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
4/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
4.1%
4/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
6.2%
6/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.0%
3/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
0.00%
0/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.0%
1/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
3.0%
3/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
2.1%
2/97 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
5.0%
5/101 • All adverse events from consent to 30 days after last dose of study drug. From randomization of first subject until 23 months later. From randomization of first subject until 33 months later (OS update).
Other Adverse Events below includes all reported treatment emergent adverse events (total of all non-serious and serious adverse events) for the provided MedDRA Preferred Terms
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60