Trial Outcomes & Findings for Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations (NCT NCT03212274)
NCT ID: NCT03212274
Last Updated: 2026-08-18
Results Overview
Will be determined by investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1 for extracranial solid tumors, Response Assessment in Neuro-Oncology criteria for intracranial glioma. Overall response rate and a 90% creditable interval in each cohort will be estimated using the approach described by Koyama. For the other solid tumors cohort, descriptive statistics and graphical displays will be used to summarize results within tumor types. Upon results entry, best overall response by cohort was presented using RECIST criteria. RECIST categories from best to worst are as follows: Complete Response (CR): The tumor has shrunk to a size that is measurable. Partial Response (PR): The tumor has not completely shrunk but has decreased in size. Stable Disease (SD): The tumor size has not changed. Progressive Disease (PD): The tumor has increased in size. These categories help in evaluating the effectiveness of cancer treatment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Up to completion of 8 weeks of treatment
Results posted on
2026-08-18
Participant Flow
Participant milestones
| Measure |
Cholangiocarcinoma Cohort-Pretreated
Cholangiocarcinoma Cohort-Pretreated
|
Cholangiocarcinoma Cohort-Treatment Naïve
Cholangiocarcinoma cohort -treatment naïve.
|
Glioblastoma Cohort-Pretreated
Glioblastoma cohort - having been pretreated.
|
Glioblastoma Cohort-Treatment Naïve
Glioblastoma cohort - treatment naïve.
|
OTHER COHORT- Treatment Naïve
OTHER Cohort- Treatment Naïve
|
Other Cohort-Pretreated
OTHER cohort - having been pretreated.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
16
|
16
|
25
|
1
|
|
Overall Study
COMPLETED
|
16
|
15
|
16
|
16
|
25
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations
Baseline characteristics by cohort
| Measure |
Cohort 1A-Glioma Naïve to IDH I
n=16 Participants
Cohort 1A-Glioma Naïve to IDH I
|
Cohort 1B- Glioma Pretreated
n=16 Participants
Cohort 1B- Glioma Pretreated
|
Cohort 2A- Cholangio Naive
n=15 Participants
Cohort 2A- Cholangio Naive
|
Cohort 2B-Cholangio- Pretreated
n=16 Participants
Cohort 2B-Cholangio- Pretreated
|
Cohort 3A Other -Naive
n=25 Participants
Cohort 3A Other -Naive
|
Cohort 3B Other -Pretreated
n=1 Participants
Cohort 3B Other -Pretreated
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=298 Participants
|
16 Participants
n=102 Participants
|
5 Participants
n=400 Participants
|
10 Participants
n=30 Participants
|
15 Participants
n=1389 Participants
|
1 Participants
n=44 Participants
|
62 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
10 Participants
n=400 Participants
|
6 Participants
n=30 Participants
|
10 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
27 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=298 Participants
|
6 Participants
n=102 Participants
|
11 Participants
n=400 Participants
|
10 Participants
n=30 Participants
|
7 Participants
n=1389 Participants
|
1 Participants
n=44 Participants
|
40 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=298 Participants
|
10 Participants
n=102 Participants
|
4 Participants
n=400 Participants
|
6 Participants
n=30 Participants
|
18 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
49 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=298 Participants
|
15 Participants
n=102 Participants
|
14 Participants
n=400 Participants
|
16 Participants
n=30 Participants
|
25 Participants
n=1389 Participants
|
1 Participants
n=44 Participants
|
87 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
3 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=298 Participants
|
14 Participants
n=102 Participants
|
13 Participants
n=400 Participants
|
13 Participants
n=30 Participants
|
24 Participants
n=1389 Participants
|
1 Participants
n=44 Participants
|
80 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=400 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
4 Participants
n=44 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=298 Participants
|
16 participants
n=102 Participants
|
15 participants
n=400 Participants
|
16 participants
n=30 Participants
|
25 participants
n=1389 Participants
|
1 participants
n=44 Participants
|
89 participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Up to completion of 8 weeks of treatmentWill be determined by investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1 for extracranial solid tumors, Response Assessment in Neuro-Oncology criteria for intracranial glioma. Overall response rate and a 90% creditable interval in each cohort will be estimated using the approach described by Koyama. For the other solid tumors cohort, descriptive statistics and graphical displays will be used to summarize results within tumor types. Upon results entry, best overall response by cohort was presented using RECIST criteria. RECIST categories from best to worst are as follows: Complete Response (CR): The tumor has shrunk to a size that is measurable. Partial Response (PR): The tumor has not completely shrunk but has decreased in size. Stable Disease (SD): The tumor size has not changed. Progressive Disease (PD): The tumor has increased in size. These categories help in evaluating the effectiveness of cancer treatment.
Outcome measures
| Measure |
Cohort 1A-Glioma Naïve to IDH I
n=16 Participants
Cohort 1A-Glioma Naïve to IDH I
|
Cohort 1B- Glioma Pretreated
n=16 Participants
Cohort 1B- Glioma Pretreated
|
Cohort 2A- Cholangio Naive
n=15 Participants
Cohort 2A- Cholangio Naive
|
Cohort 2B-Cholangio- Pretreated
n=16 Participants
Cohort 2B-Cholangio- Pretreated
|
Cohort 3A Other -Naive
n=25 Participants
Cohort 3A Other -Naive
|
Cohort 3B Other -Pretreated
n=1 Participants
Cohort 3B Other -Pretreated
|
|---|---|---|---|---|---|---|
|
Overall Response Rate
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Stable Disease (SD)
|
9 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
1 Participants
|
|
Overall Response Rate
Progressive Disease (PD)
|
6 Participants
|
5 Participants
|
9 Participants
|
4 Participants
|
15 Participants
|
0 Participants
|
|
Overall Response Rate
Not Evaluable
|
1 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed up to 3.6 yearsFor time to event endpoints, Kaplan-Meier curves will be used to demonstrate distributions and median estimates will be reported with 95% confidence intervals. For each cohort, graphical displays such as swimmer plots, will be used to demonstrate patterns of response, progression and death, and in the third cohort they will also indicate disease type. At the time of results entry, median PFS is provided per cohort.
Outcome measures
| Measure |
Cohort 1A-Glioma Naïve to IDH I
n=16 Participants
Cohort 1A-Glioma Naïve to IDH I
|
Cohort 1B- Glioma Pretreated
n=16 Participants
Cohort 1B- Glioma Pretreated
|
Cohort 2A- Cholangio Naive
n=15 Participants
Cohort 2A- Cholangio Naive
|
Cohort 2B-Cholangio- Pretreated
n=16 Participants
Cohort 2B-Cholangio- Pretreated
|
Cohort 3A Other -Naive
n=25 Participants
Cohort 3A Other -Naive
|
Cohort 3B Other -Pretreated
n=1 Participants
Cohort 3B Other -Pretreated
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
109 days
Interval 53.0 to 364.0
|
114 days
Interval 13.0 to 1365.0
|
51 days
Interval 10.0 to 390.0
|
61 days
Interval 8.0 to 280.0
|
55 days
Interval 0.0 to 259.0
|
85 days
Interval 85.0 to 85.0
|
SECONDARY outcome
Timeframe: Up to 3.6 yearsAdverse events will be tabulated by type and grade in each cohort, and also across cohorts. At the time of results entry, presented are the counts of individuals that experienced any Non-Serious Adverse Event, and the counts of individuals that experienced any Serious Adverse Event
Outcome measures
| Measure |
Cohort 1A-Glioma Naïve to IDH I
n=16 Participants
Cohort 1A-Glioma Naïve to IDH I
|
Cohort 1B- Glioma Pretreated
n=16 Participants
Cohort 1B- Glioma Pretreated
|
Cohort 2A- Cholangio Naive
n=15 Participants
Cohort 2A- Cholangio Naive
|
Cohort 2B-Cholangio- Pretreated
n=16 Participants
Cohort 2B-Cholangio- Pretreated
|
Cohort 3A Other -Naive
n=25 Participants
Cohort 3A Other -Naive
|
Cohort 3B Other -Pretreated
n=1 Participants
Cohort 3B Other -Pretreated
|
|---|---|---|---|---|---|---|
|
Incidence of Adverse Events
Experienced Serious Adverse Event
|
3 Participants
|
4 Participants
|
10 Participants
|
2 Participants
|
11 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Experienced Non-Serious Adverse Event
|
15 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
22 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to post-treatmentAbsolute and fold changes for exploratory endpoints will be calculated between baseline and each subsequent follow-up time point. These will be displayed graphically versus (vs.) time for each cohort. Differences will be plotted vs. response status. Paired t-tests will be used to evaluate if differences between baseline and each subsequent time point are significant. Summary statistics will be reported (with 95% confidence intervals) to demonstrate mean differences in fold-change (or log fold-change) between responders and non-responders.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3.6 yearsAbsolute and fold changes for exploratory endpoints will be calculated between baseline and each subsequent follow-up time point. These will be displayed graphically vs. time for each cohort. Differences will be plotted vs. response status. Paired t-tests will be used to evaluate if differences between baseline and each subsequent time point are significant. Summary statistics will be reported (with 95% confidence intervals) to demonstrate mean differences in fold-change (or log fold-change) between responders and non-responders.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3.6 yearsWill be detected via mass cytometry, ribonucleic acid sequencing and/or deoxyribonucleic acid sequencing. Will be associated with differential levels of 2HG production, treatment response and resistance. Absolute and fold changes for exploratory endpoints will be calculated between baseline and each subsequent follow-up time point. These will be displayed graphically vs. time for each cohort. Differences will be plotted vs. response status. Paired t-tests will be used to evaluate if differences between baseline and each subsequent time point are significant. Summary statistics will be reported (with 95% confidence intervals) to demonstrate mean differences in fold-change (or log fold-change) between responders and non-responders.
Outcome measures
Outcome data not reported
Adverse Events
Cholangiocarcinoma Cohort-Pretreated
Serious events: 2 serious events
Other events: 15 other events
Deaths: 2 deaths
Cholangiocarcinoma Cohort-Treatment Naïve
Serious events: 10 serious events
Other events: 14 other events
Deaths: 11 deaths
Glioblastoma Cohort-Pretreated
Serious events: 4 serious events
Other events: 14 other events
Deaths: 8 deaths
Glioblastoma Cohort-Treatment Naïve
Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths
OTHER COHORT- Treatment Naïve
Serious events: 11 serious events
Other events: 22 other events
Deaths: 15 deaths
Other Cohort-Pretreated
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cholangiocarcinoma Cohort-Pretreated
n=16 participants at risk
Cholangiocarcinoma cohort - having been pretreated.
|
Cholangiocarcinoma Cohort-Treatment Naïve
n=15 participants at risk
Cholangiocarcinoma cohort -treatment naïve.
|
Glioblastoma Cohort-Pretreated
n=16 participants at risk
Glioblastoma cohort - having been pretreated.
|
Glioblastoma Cohort-Treatment Naïve
n=16 participants at risk
Glioblastoma cohort - treatment naïve.
|
OTHER COHORT- Treatment Naïve
n=25 participants at risk
OTHER cohort - treatment naïve.
|
Other Cohort-Pretreated
n=1 participants at risk
OTHER cohort - having been pretreated.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Loss Of Sphincter Control
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Chills
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Death NOS
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Disease progression
|
0.00%
0/16 • Up to 3.6 years
|
13.3%
2/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Fever
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
General disorders and administration site conditions - Other, specify - Disease Progression
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
General disorders and administration site conditions - Other, specify - Progressive Disease
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Creatinine increased
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
8.0%
2/25 • Number of events 3 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
8.0%
2/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify - Intracranial Hemorrhage
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
8.0%
2/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Vascular disorders
Vascular disorders - Other, specify - Lle Dvt
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/16 • Up to 3.6 years
|
13.3%
2/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Up to 3.6 years
|
13.3%
2/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Pain
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify - Biliary Obstruction
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify - Blockage Biliary Tract
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Infections and infestations - Other, specify - Cvodi-19
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Infections and infestations - Other, specify - Sepsis
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
Other adverse events
| Measure |
Cholangiocarcinoma Cohort-Pretreated
n=16 participants at risk
Cholangiocarcinoma cohort - having been pretreated.
|
Cholangiocarcinoma Cohort-Treatment Naïve
n=15 participants at risk
Cholangiocarcinoma cohort -treatment naïve.
|
Glioblastoma Cohort-Pretreated
n=16 participants at risk
Glioblastoma cohort - having been pretreated.
|
Glioblastoma Cohort-Treatment Naïve
n=16 participants at risk
Glioblastoma cohort - treatment naïve.
|
OTHER COHORT- Treatment Naïve
n=25 participants at risk
OTHER cohort - treatment naïve.
|
Other Cohort-Pretreated
n=1 participants at risk
OTHER cohort - having been pretreated.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Loss Of Appetite
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Broken Tooth
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 4 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Gi Spasm
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Investigations - Other, specify - Creatinine Clearance Decreased
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Motion Sickness
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Tooth Decay
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • Number of events 5 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Nausea
|
37.5%
6/16 • Number of events 16 • Up to 3.6 years
|
20.0%
3/15 • Number of events 17 • Up to 3.6 years
|
43.8%
7/16 • Number of events 13 • Up to 3.6 years
|
68.8%
11/16 • Number of events 47 • Up to 3.6 years
|
32.0%
8/25 • Number of events 21 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
4.0%
1/25 • Number of events 4 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Number of events 5 • Up to 3.6 years
|
26.7%
4/15 • Number of events 4 • Up to 3.6 years
|
31.2%
5/16 • Number of events 5 • Up to 3.6 years
|
31.2%
5/16 • Number of events 7 • Up to 3.6 years
|
20.0%
5/25 • Number of events 7 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Chills
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Edema limbs
|
12.5%
2/16 • Number of events 11 • Up to 3.6 years
|
13.3%
2/15 • Number of events 9 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
8.0%
2/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Fatigue
|
37.5%
6/16 • Number of events 16 • Up to 3.6 years
|
40.0%
6/15 • Number of events 23 • Up to 3.6 years
|
31.2%
5/16 • Number of events 28 • Up to 3.6 years
|
50.0%
8/16 • Number of events 52 • Up to 3.6 years
|
48.0%
12/25 • Number of events 28 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Fever
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
12.5%
2/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
8.0%
2/25 • Number of events 10 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Gait disturbance
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
General disorders and administration site conditions - Other, specify - Failure To Thrive
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • Up to 3.6 years
|
13.3%
2/15 • Number of events 2 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Pain
|
0.00%
0/16 • Up to 3.6 years
|
13.3%
2/15 • Number of events 7 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
12.0%
3/25 • Number of events 4 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Hepatobiliary disorders
Hepatic pain
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Immune system disorders
Immune system disorders - Other, specify - Elevated Leucocytic Count
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Immune system disorders
Immune system disorders - Other, specify - Mrsa
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Bacteremia
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Infections and infestations - Other, specify - Spontaneous Bacterial Peritonitis
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Infections and infestations - Other, specify - Stomach
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Myelitis
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Shingles
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 5 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Thrush
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 4 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify - Hemoptysis
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Blood bilirubin increased
|
12.5%
2/16 • Number of events 2 • Up to 3.6 years
|
33.3%
5/15 • Number of events 6 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
6.2%
1/16 • Number of events 47 • Up to 3.6 years
|
25.0%
4/16 • Number of events 16 • Up to 3.6 years
|
12.0%
3/25 • Number of events 9 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Creatinine increased
|
25.0%
4/16 • Number of events 15 • Up to 3.6 years
|
26.7%
4/15 • Number of events 11 • Up to 3.6 years
|
12.5%
2/16 • Number of events 4 • Up to 3.6 years
|
25.0%
4/16 • Number of events 10 • Up to 3.6 years
|
12.0%
3/25 • Number of events 3 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
GGT increased
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
26.7%
4/15 • Number of events 12 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
8.0%
2/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
INR increased
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Investigations - Other, specify - Abdominal Cramping
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 3 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Investigations - Other, specify - Blood In Stool
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify - Altered Mental Status
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 5 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 10 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Investigations - Other, specify - Diploplia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Investigations - Other, specify - Elevated Ldh
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Investigations - Other, specify - Increase Ldh
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Investigations - Other, specify - Ldh Increase
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Investigations - Other, specify - Naval Drainage/Rash
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Lymphocyte count decreased
|
12.5%
2/16 • Number of events 8 • Up to 3.6 years
|
40.0%
6/15 • Number of events 14 • Up to 3.6 years
|
18.8%
3/16 • Number of events 6 • Up to 3.6 years
|
18.8%
3/16 • Number of events 9 • Up to 3.6 years
|
12.0%
3/25 • Number of events 4 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
25.0%
4/16 • Number of events 9 • Up to 3.6 years
|
12.5%
2/16 • Number of events 3 • Up to 3.6 years
|
8.0%
2/25 • Number of events 4 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Platelet count decreased
|
18.8%
3/16 • Number of events 8 • Up to 3.6 years
|
33.3%
5/15 • Number of events 7 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
18.8%
3/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Weight loss
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
16.0%
4/25 • Number of events 12 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
White blood cell decreased
|
18.8%
3/16 • Number of events 4 • Up to 3.6 years
|
20.0%
3/15 • Number of events 6 • Up to 3.6 years
|
18.8%
3/16 • Number of events 6 • Up to 3.6 years
|
12.5%
2/16 • Number of events 6 • Up to 3.6 years
|
12.0%
3/25 • Number of events 5 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
20.0%
3/15 • Number of events 5 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
12.5%
2/16 • Number of events 3 • Up to 3.6 years
|
28.0%
7/25 • Number of events 21 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
2/16 • Number of events 5 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
12.5%
2/16 • Number of events 8 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Number of events 5 • Up to 3.6 years
|
13.3%
2/15 • Number of events 4 • Up to 3.6 years
|
12.5%
2/16 • Number of events 7 • Up to 3.6 years
|
31.2%
5/16 • Number of events 36 • Up to 3.6 years
|
8.0%
2/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
12.5%
2/16 • Number of events 2 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
12.5%
2/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/16 • Up to 3.6 years
|
33.3%
5/15 • Number of events 15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
6.2%
1/16 • Number of events 4 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 8 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/16 • Up to 3.6 years
|
13.3%
2/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
12.5%
2/16 • Number of events 5 • Up to 3.6 years
|
8.0%
2/25 • Number of events 4 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/16 • Up to 3.6 years
|
20.0%
3/15 • Number of events 4 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
26.7%
4/15 • Number of events 8 • Up to 3.6 years
|
12.5%
2/16 • Number of events 5 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
12.0%
3/25 • Number of events 6 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
8.0%
2/25 • Number of events 6 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 4 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 7 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 13 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Renal and urinary disorders
Urine discoloration
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
13.3%
2/15 • Number of events 7 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
12.5%
2/16 • Number of events 5 • Up to 3.6 years
|
12.0%
3/25 • Number of events 4 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
20.0%
3/15 • Number of events 13 • Up to 3.6 years
|
12.5%
2/16 • Number of events 4 • Up to 3.6 years
|
6.2%
1/16 • Number of events 13 • Up to 3.6 years
|
28.0%
7/25 • Number of events 21 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 11 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 12 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
6.7%
1/15 • Number of events 3 • Up to 3.6 years
|
18.8%
3/16 • Number of events 3 • Up to 3.6 years
|
12.5%
2/16 • Number of events 5 • Up to 3.6 years
|
12.0%
3/25 • Number of events 15 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
12.5%
2/16 • Number of events 47 • Up to 3.6 years
|
12.5%
2/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify - Imbalance
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 5 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify - Mild Facial Droop
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify - Pre-Seizure
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Paresthesia
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 8 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 13 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
6.2%
1/16 • Number of events 12 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
12.5%
2/16 • Number of events 18 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
12.5%
2/16 • Number of events 17 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
25.0%
4/16 • Number of events 4 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
12.5%
2/16 • Number of events 11 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.2%
1/16 • Number of events 4 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 4 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
12.5%
2/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Vascular disorders
Arterial thromboembolism
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/16 • Up to 3.6 years
|
13.3%
2/15 • Number of events 8 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
31.2%
5/16 • Number of events 30 • Up to 3.6 years
|
8.0%
2/25 • Number of events 3 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Vascular disorders
Thromboembolic event
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Vascular disorders
Vascular disorders - Other, specify - Thromboembolic Event, Bilateral Pulmonary Embolism
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Dysgeusia
|
18.8%
3/16 • Number of events 11 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 6 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
4.0%
1/25 • Number of events 3 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Number of events 10 • Up to 3.6 years
|
6.7%
1/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
25.0%
4/16 • Number of events 8 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
8.0%
2/25 • Number of events 3 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
1/16 • Number of events 5 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
18.8%
3/16 • Number of events 21 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Eye disorders
Eye disorders - Other, specify - Light Sensitivity
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Eye disorders
Periorbital edema
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • Number of events 4 • Up to 3.6 years
|
26.7%
4/15 • Number of events 6 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 13 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Ascites
|
12.5%
2/16 • Number of events 3 • Up to 3.6 years
|
6.7%
1/15 • Number of events 4 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Number of events 4 • Up to 3.6 years
|
20.0%
3/15 • Number of events 12 • Up to 3.6 years
|
6.2%
1/16 • Number of events 6 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Constipation
|
18.8%
3/16 • Number of events 12 • Up to 3.6 years
|
13.3%
2/15 • Number of events 5 • Up to 3.6 years
|
31.2%
5/16 • Number of events 27 • Up to 3.6 years
|
18.8%
3/16 • Number of events 5 • Up to 3.6 years
|
24.0%
6/25 • Number of events 15 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
20.0%
3/15 • Number of events 8 • Up to 3.6 years
|
12.5%
2/16 • Number of events 5 • Up to 3.6 years
|
18.8%
3/16 • Number of events 17 • Up to 3.6 years
|
8.0%
2/25 • Number of events 4 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 4 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 10 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 4 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
6.7%
1/15 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Black, Tarry Stools
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify - Ptt Increased
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Blood and lymphatic system disorders
Anemia
|
43.8%
7/16 • Number of events 28 • Up to 3.6 years
|
46.7%
7/15 • Number of events 49 • Up to 3.6 years
|
12.5%
2/16 • Number of events 30 • Up to 3.6 years
|
25.0%
4/16 • Number of events 4 • Up to 3.6 years
|
44.0%
11/25 • Number of events 26 • Up to 3.6 years
|
100.0%
1/1 • Number of events 1 • Up to 3.6 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify - Macrocytosis
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 4 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
General disorders and administration site conditions - Other, specify - Lactic Acidosis
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
General disorders and administration site conditions - Other, specify - Lightheadness
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
General disorders and administration site conditions - Other, specify - New Tonsil Cancer
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 3 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Generalized edema
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
General disorders
Localized edema
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 2 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 3 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 14 • Up to 3.6 years
|
6.2%
1/16 • Number of events 3 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
26.7%
4/15 • Number of events 7 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
46.7%
7/15 • Number of events 12 • Up to 3.6 years
|
12.5%
2/16 • Number of events 2 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
20.0%
3/15 • Number of events 5 • Up to 3.6 years
|
12.5%
2/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 5 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify - Body Tenseness
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify - Muscle Spasm
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify - Osteoarthritis
|
6.2%
1/16 • Number of events 5 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Up to 3.6 years
|
13.3%
2/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Cauda Equina Syndrome
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Sebaceous Cyst
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Anosmia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 6 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 2 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 13 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 5 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
12.5%
2/16 • Number of events 6 • Up to 3.6 years
|
12.5%
2/16 • Number of events 6 • Up to 3.6 years
|
20.0%
5/25 • Number of events 8 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Acute Hypoxemic Respiratory Failure
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 1 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify - Bronchitis
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify - Common Cold
|
0.00%
0/16 • Up to 3.6 years
|
6.7%
1/15 • Number of events 2 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
4.0%
1/25 • Number of events 2 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/16 • Up to 3.6 years
|
0.00%
0/15 • Up to 3.6 years
|
0.00%
0/16 • Up to 3.6 years
|
6.2%
1/16 • Number of events 1 • Up to 3.6 years
|
0.00%
0/25 • Up to 3.6 years
|
0.00%
0/1 • Up to 3.6 years
|
Additional Information
Philippos Costa, MD, Assistant Professor of Medicine (Medical Oncology and Hematology)
Yale School of Medicine
Phone: (203) 785-2579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60