Trial Outcomes & Findings for 8-Chloroadenosine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT02509546)
NCT ID: NCT02509546
Last Updated: 2023-12-05
Results Overview
According to the standard 3+3 rules, where the highest DL that produced ≤ 1/6 DLTs in cycle 1 would be defined as the maximum tolerated dose (MTD). The RP2D of 8-Cl-Ado would generally be the MTD, but it could be less than the initially calculated MTD as determined from a review of the available data and cumulative toxicities from phase 1.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 28 days following first study agent administration.
Results posted on
2023-12-05
Participant Flow
The phase 2 portion was not pursued since no marrow complete remissions were observed with single agent therapy and a decision was made to pursue a combination trial with the Bcl-2 inhibitor venetoclax based on preclinical data.
Participant milestones
| Measure |
Phase I - 100mg/m^2 1-hour Infusion
100mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 200mg/m^2 1-hour Infusion
200mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 1-hour Infusion
400mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 800mg/m^2 1-hour Infusion
800mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 4-hour Infusion
400mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 600mg/m^2 4-hour Infusion
600mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
2
|
2
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
4
|
2
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
8-Chloroadenosine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Phase I - 100mg/m^2 8-chloro-adenosine 1-hour Infusion
n=3 Participants
100mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion
n=3 Participants
200mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion
n=4 Participants
400mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion
n=2 Participants
800mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion
n=2 Participants
400mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion
n=6 Participants
600mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
75 years
n=93 Participants
|
54 years
n=4 Participants
|
59 years
n=27 Participants
|
56 years
n=483 Participants
|
68 years
n=36 Participants
|
70 years
n=10 Participants
|
66 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
2 participants
n=483 Participants
|
2 participants
n=36 Participants
|
6 participants
n=10 Participants
|
20 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days following first study agent administration.Population: 3 patients at 100 mg/m\^2 1-hr; 3 patients at 200 mg/m\^2 1-hr; 4 patients at 400 mg/m\^2 1-hr; 2 patients at 800 mg/m\^2 1-hr; 2 patients at 400 mg/m\^2 4-hr; 6 patients at 600 mg/m\^2 4-hr.
According to the standard 3+3 rules, where the highest DL that produced ≤ 1/6 DLTs in cycle 1 would be defined as the maximum tolerated dose (MTD). The RP2D of 8-Cl-Ado would generally be the MTD, but it could be less than the initially calculated MTD as determined from a review of the available data and cumulative toxicities from phase 1.
Outcome measures
| Measure |
Phase I - Treatment (8-chloro-adenosine)
n=20 Participants
Patients receive 8-chloro-adenosine IV on days 1-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion
200mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion
400mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion
800mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion
400mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion
600mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
|---|---|---|---|---|---|---|
|
Recommended Phase II Dose (RP2D) of 8-Chloro-adenosine (8-Cl-Ado)
|
400 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days following first study agent administration.Toxicity was graded according to the NCI-Common Terminology Criteria for Adverse Events version 4.03. A DLT was defined as any of the following toxicities (please see the details in section of 13.2 of the protocol) that occur during cycle 1, per CTCAE version 4.03, and were considered related to the study drug.
Outcome measures
| Measure |
Phase I - Treatment (8-chloro-adenosine)
n=3 Participants
Patients receive 8-chloro-adenosine IV on days 1-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion
n=3 Participants
200mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion
n=4 Participants
400mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion
n=2 Participants
800mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion
n=2 Participants
400mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion
n=6 Participants
600mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
|---|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years following first study agent administration.Complete remission rate (CR + CRi) based on the Döhner 2010 criteria and calculated as the percent of evaluable patients that have confirmed CR or CRi is to evaluate the antitumor activity of 8-chloro-adenosine.
Outcome measures
| Measure |
Phase I - Treatment (8-chloro-adenosine)
n=3 Participants
Patients receive 8-chloro-adenosine IV on days 1-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion
n=3 Participants
200mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion
n=4 Participants
400mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion
n=2 Participants
800mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion
n=2 Participants
400mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion
n=6 Participants
600mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
|---|---|---|---|---|---|---|
|
Complete Remission Rate (CR + CRi)
|
0 Percent of evaluable patients
|
0 Percent of evaluable patients
|
0 Percent of evaluable patients
|
0 Percent of evaluable patients
|
0 Percent of evaluable patients
|
0 Percent of evaluable patients
|
Adverse Events
Phase I - 100mg/m^2 8-chloro-adenosine 1-hour Infusion
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Phase I - 100mg/m^2 8-chloro-adenosine 1-hour Infusion
n=3 participants at risk
100mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion
n=3 participants at risk
200mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion
n=4 participants at risk
400mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion
n=2 participants at risk
800mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion
n=2 participants at risk
400mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion
n=6 participants at risk
600mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
General disorders
MULTIORGAN FAILURE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
ASPERGUILLUS GALACTOMANNAN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DISEASE PROGRESSION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKEMIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
INVASIVE PULMONARY ASPERGILLOSIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
Other adverse events
| Measure |
Phase I - 100mg/m^2 8-chloro-adenosine 1-hour Infusion
n=3 participants at risk
100mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion
n=3 participants at risk
200mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion
n=4 participants at risk
400mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion
n=2 participants at risk
800mg/m\^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion
n=2 participants at risk
400mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion
n=6 participants at risk
600mg/m\^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
100.0%
3/3 • Number of events 33 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 46 • Up to 2 years following first study agent administration.
|
75.0%
3/4 • Number of events 31 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 16 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 20 • Up to 2 years following first study agent administration.
|
100.0%
6/6 • Number of events 48 • Up to 2 years following first study agent administration.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 6 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Blood and lymphatic system disorders
LYMPH NODE PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
ATRIAL ARRHYTHMIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 5 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
CARDIOMEGALY
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
CHEST PAIN CARDIAC
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
DILATED CARDIOMYOPATHY
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
HEART FAILURE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
MYOCARDITIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
PAROXYSMAL ATRIAL TACHYCARDIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 17 • Up to 2 years following first study agent administration.
|
75.0%
3/4 • Number of events 5 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
100.0%
6/6 • Number of events 17 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
SUPERVENTRICULAR SINUS TACYCARDIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
T WAVE CHANGES
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Eye disorders
DRY EYE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Eye disorders
WATERING EYES
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 4 • Up to 2 years following first study agent administration.
|
75.0%
3/4 • Number of events 5 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
BLOATING
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
CONSTIPATION
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 5 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
DIARRHEA
|
66.7%
2/3 • Number of events 5 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 7 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 6 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
75.0%
3/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HEMORRHAGE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
33.3%
1/3 • Number of events 6 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 6 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 10 • Up to 2 years following first study agent administration.
|
75.0%
3/4 • Number of events 7 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 6 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 9 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 9 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 15 • Up to 2 years following first study agent administration.
|
|
General disorders
CHILLS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
General disorders
DIAPHORESIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
General disorders
EDEMA FACE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
General disorders
EDEMA LIMBS
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 4 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 8 • Up to 2 years following first study agent administration.
|
|
General disorders
FACIAL PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
General disorders
FATIGUE
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 22 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 3 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 6 • Up to 2 years following first study agent administration.
|
|
General disorders
FEVER
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 7 • Up to 2 years following first study agent administration.
|
100.0%
4/4 • Number of events 10 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 7 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 6 • Up to 2 years following first study agent administration.
|
|
General disorders
FLUID OVERLOAD
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
General disorders
LOCALIZED EDEMA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
General disorders
MALAISE
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
General disorders
MULTIORGAN FAILURE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
General disorders
NONCARDIAC CHEST PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
General disorders
PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
General disorders
PAIN AT IV SITE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Immune system disorders
ALLERGIC REACTION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
C. DIFFICILE COLITIS
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Injury, poisoning and procedural complications
BRUISING
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 4 • Up to 2 years following first study agent administration.
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 5 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 6 • Up to 2 years following first study agent administration.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
100.0%
3/3 • Number of events 8 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 12 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 5 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 4 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 3 • Up to 2 years following first study agent administration.
|
100.0%
6/6 • Number of events 17 • Up to 2 years following first study agent administration.
|
|
Investigations
CARDIAC TROPONIN I INCREASED
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Investigations
CARDIAC TROPONIN T INCREASED
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Investigations
CPK INCREASED
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Investigations
CREATININE INCREASED
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 7 • Up to 2 years following first study agent administration.
|
|
Investigations
EJECTION FRACTION DECREASED
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Investigations
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED
|
66.7%
2/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 3 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 23 • Up to 2 years following first study agent administration.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
66.7%
2/3 • Number of events 9 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 21 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 17 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 10 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 3 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 11 • Up to 2 years following first study agent administration.
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
33.3%
1/3 • Number of events 10 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 6 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 8 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 30 • Up to 2 years following first study agent administration.
|
|
Investigations
PLATELET COUNT DECREASED
|
100.0%
3/3 • Number of events 59 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 52 • Up to 2 years following first study agent administration.
|
75.0%
3/4 • Number of events 6 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 25 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 36 • Up to 2 years following first study agent administration.
|
|
Investigations
WEIGHT GAIN
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Investigations
WEIGHT LOSS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 16 • Up to 2 years following first study agent administration.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
100.0%
3/3 • Number of events 13 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 10 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 6 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 5 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 6 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 20 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
ALKALOSIS
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 6 • Up to 2 years following first study agent administration.
|
75.0%
3/4 • Number of events 4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 5 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
33.3%
1/3 • Number of events 10 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 7 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 5 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 4 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
100.0%
3/3 • Number of events 12 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 15 • Up to 2 years following first study agent administration.
|
100.0%
4/4 • Number of events 10 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
100.0%
6/6 • Number of events 19 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
100.0%
3/3 • Number of events 10 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 5 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 4 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
66.7%
2/3 • Number of events 13 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 12 • Up to 2 years following first study agent administration.
|
100.0%
4/4 • Number of events 10 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 15 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
100.0%
6/6 • Number of events 28 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
66.7%
2/3 • Number of events 7 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 11 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
100.0%
3/3 • Number of events 14 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 8 • Up to 2 years following first study agent administration.
|
75.0%
3/4 • Number of events 6 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 10 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 17 • Up to 2 years following first study agent administration.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
66.7%
2/3 • Number of events 5 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
75.0%
3/4 • Number of events 9 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 14 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 2 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 12 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 3 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 4 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
83.3%
5/6 • Number of events 8 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
JOINT RANGE OF MOTION DECREASED
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
LEFT SCAPULA PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER PAIN
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOGENOUS LEUKEMIA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKEMIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DISEASE PROGRESSION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
REFRACTORY RELAPSED ACUTE MYELOID LEUKEMIA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
DIZZINESS
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
DYSARTHRIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
HEADACHE
|
33.3%
1/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 8 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
LETHARGY
|
33.3%
1/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 4 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
SOMNOLENCE
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Nervous system disorders
TREMOR
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Psychiatric disorders
AGITATION
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 4 • Up to 2 years following first study agent administration.
|
|
Psychiatric disorders
ANXIETY
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 6 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 6 • Up to 2 years following first study agent administration.
|
|
Psychiatric disorders
CONFUSION
|
33.3%
1/3 • Number of events 4 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 6 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 5 • Up to 2 years following first study agent administration.
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Renal and urinary disorders
FLUID RETENTION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Renal and urinary disorders
HEMATURIA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Renal and urinary disorders
PROTEINURIA
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Reproductive system and breast disorders
GENITAL EDEMA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Reproductive system and breast disorders
PERINEAL PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Reproductive system and breast disorders
SCROTAL EDEMA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Reproductive system and breast disorders
VAGINAL HEMORRHAGE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 4 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPULMONARY HEMORRHAGE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 6 • Up to 2 years following first study agent administration.
|
50.0%
2/4 • Number of events 2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
DECREASED FEV
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
66.7%
2/3 • Number of events 4 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
100.0%
4/4 • Number of events 6 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 8 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 5 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
FUNGAL SINUSITIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
GENERALIZED EDEMA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
66.7%
2/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 11 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL HEMORRHAGE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL INFLAMMATION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
LIGHT GRAM POSITIVE COCCI
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATES
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 2 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY INFILTRATES
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHEA
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
RUNNY NOSE
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 3 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
50.0%
3/6 • Number of events 3 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNEA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 4 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
DIAPHORESIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMATOUS FOLLICULAR RASH
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
66.7%
2/3 • Number of events 2 • Up to 2 years following first study agent administration.
|
25.0%
1/4 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
PALMARPLANTAR ERYTHRODYSESTHESIA SYNDROME
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
PERIORBITAL EDEMA
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
PETICHIAE (CHEST)
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLORATION (HANDS)
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLORATION FEET
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
33.3%
2/6 • Number of events 2 • Up to 2 years following first study agent administration.
|
|
Surgical and medical procedures
HICKMAN SITE DISCOMFORT
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
16.7%
1/6 • Number of events 1 • Up to 2 years following first study agent administration.
|
|
Vascular disorders
HEMATOMAS
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
|
Vascular disorders
HYPERTENSION
|
100.0%
3/3 • Number of events 23 • Up to 2 years following first study agent administration.
|
100.0%
3/3 • Number of events 21 • Up to 2 years following first study agent administration.
|
100.0%
4/4 • Number of events 9 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 10 • Up to 2 years following first study agent administration.
|
100.0%
2/2 • Number of events 18 • Up to 2 years following first study agent administration.
|
100.0%
6/6 • Number of events 31 • Up to 2 years following first study agent administration.
|
|
Vascular disorders
HYPOTENSION
|
66.7%
2/3 • Number of events 4 • Up to 2 years following first study agent administration.
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
50.0%
1/2 • Number of events 1 • Up to 2 years following first study agent administration.
|
66.7%
4/6 • Number of events 6 • Up to 2 years following first study agent administration.
|
|
Vascular disorders
SUPERFICIAL THROMBOPHLEBITIS
|
0.00%
0/3 • Up to 2 years following first study agent administration.
|
33.3%
1/3 • Number of events 1 • Up to 2 years following first study agent administration.
|
0.00%
0/4 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/2 • Up to 2 years following first study agent administration.
|
0.00%
0/6 • Up to 2 years following first study agent administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place