Trial Outcomes & Findings for Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Relapsed/Refractory Multiple Myeloma (NCT NCT02119468)
NCT ID: NCT02119468
Last Updated: 2024-03-15
Results Overview
Dose Limiting Toxicity (DLT) is defined as any of the toxicities in Section 7.3 that are at least possibly related to either Pomalidomide or MLN9708 that occur during cycle 1. Toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03. The highest dose level that produces 1/6 dose-limiting toxicities (DLTs) in course 1 will be the maximum tolerated dose (MTD). The RP2D of ixazomib and pomalidomide will generally be the MTD, but it may be less than the MTD based on a review of available data/cumulative toxicities from phase I.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
From the initial treatment to Day 28 (Cycle #1)
Results posted on
2024-03-15
Participant Flow
Participant milestones
| Measure |
Dose Level #1 (3mg MLN9708)
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ixazomib citrate: Given orally
dexamethasone: Given orally
pomalidomide: Given orally
|
Dose Level #2 (4mg MLN9708)
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
25
|
|
Overall Study
COMPLETED
|
7
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Dose Level #1 (3mg MLN9708)
n=7 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ixazomib citrate: Given orally
dexamethasone: Given orally
pomalidomide: Given orally
|
Dose Level #2 (4mg MLN9708)
n=25 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ixazomib citrate: Given orally
dexamethasone: Given orally
pomalidomide: Given orally
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=39 Participants
|
63 years
n=41 Participants
|
62 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From the initial treatment to Day 28 (Cycle #1)Population: Patients were considered evaluable for DLT if receiving at least 75% of both Pomalidomide and MLN9708 and followed for the full 28 days during cycle 1 or experience a DLT. All patients who are not evaluable for DLT were replaced.
Dose Limiting Toxicity (DLT) is defined as any of the toxicities in Section 7.3 that are at least possibly related to either Pomalidomide or MLN9708 that occur during cycle 1. Toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03. The highest dose level that produces 1/6 dose-limiting toxicities (DLTs) in course 1 will be the maximum tolerated dose (MTD). The RP2D of ixazomib and pomalidomide will generally be the MTD, but it may be less than the MTD based on a review of available data/cumulative toxicities from phase I.
Outcome measures
| Measure |
Dose Level #1: 3mg MLN9708
n=6 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level #2: 4mg MLN9708
n=6 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Patients With Dose-Limiting Toxicities (Phase I)
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the initial treatment to 24 monthsPopulation: Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
Over response rate is calculated as the percent of evaluable patients that have confirmed stringent complete remission (sCR), complete remission (CR), very good partial remission (VGPR) or partial remission \[PR\]) per modified IMWG criteria. sCR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow. CR defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR defined as serum and urine M-protein detectable or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h. PR defined as \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h. The exact 95% confidence intervals are calculated for the estimate.
Outcome measures
| Measure |
Dose Level #1: 3mg MLN9708
n=25 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level #2: 4mg MLN9708
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Response Rate at the Recommended Phase II Dose (RP2D)
|
48 Percentage of Participants (%)
Interval 27.8 to 68.7
|
—
|
PRIMARY outcome
Timeframe: From the initial treatment to Day 28 (Cycle #1)Population: 6 patients treated at dose level #2 in Phase I are evaluable for dose limiting toxicity.
The highest dose level that produces 1/6 dose-limiting toxicities (DLTs) in Cycle #1 will be the maximum tolerated dose (MTD). The RP2D of ixazomib and pomalidomide will generally be the MTD, but it may be less than the MTD based on a review of available data/cumulative toxicities from phase I.
Outcome measures
| Measure |
Dose Level #1: 3mg MLN9708
n=6 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level #2: 4mg MLN9708
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of MLN9708 (Phase I)
|
4 mg
|
—
|
SECONDARY outcome
Timeframe: Time interval from the date of first documented response (sCR/CR/VGPR or PR) to documented disease relapse, progression or death whichever occurs first, up to 24 monthsPopulation: Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
Time from the date of first documented response (sCR/CR/VGPR or PR) to documented disease relapse, progression or death whichever occurs first. sCR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow. CR defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR defined as serum and urine M-protein detectable or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h. PR defined as \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h.
Outcome measures
| Measure |
Dose Level #1: 3mg MLN9708
n=25 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level #2: 4mg MLN9708
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Response at the Recommended Phase II Dose (RP2D)
|
9.2 Months
Interval 0.9 to 13.9
|
—
|
SECONDARY outcome
Timeframe: From the initial treatment up to 24 monthsPopulation: Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
Clinical benefit response rate is calculated as the percent of evaluable patients that have confirmed stringent complete remission (sCR), complete remission (CR), very good partial remission (VGPR), partial remission (PR), minimal response (MR) or stable disease (SD) per modified IMWG criteria. The exact 95% confidence intervals are calculated for the estimate.
Outcome measures
| Measure |
Dose Level #1: 3mg MLN9708
n=25 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level #2: 4mg MLN9708
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Clinical Benefit Response Rate at the Recommended Phase II Dose (RP2D)
|
76 Percentage of Participants (%)
Interval 54.9 to 90.6
|
—
|
SECONDARY outcome
Timeframe: Date of first dose of study drug to date of death from any cause, up to 24 months. And the median follow-up for the surviving patients is at least one year.Population: Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
Overall survival (OS) was measured from initial treatment to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula.
Outcome measures
| Measure |
Dose Level #1: 3mg MLN9708
n=25 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level #2: 4mg MLN9708
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
One-Year Overall Survival at the Recommended Phase II Dose (RP2D)
|
82 Percentage of Participants (%)
Interval 59.0 to 93.0
|
—
|
SECONDARY outcome
Timeframe: Date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first, up to 24 months. And the median follow-up for the surviving patients is at least one year.Population: Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
Progression-free survival (PFS) was defined as time from initial treatment to recurrence, progression or death. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula \[Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.\]
Outcome measures
| Measure |
Dose Level #1: 3mg MLN9708
n=25 Participants
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level #2: 4mg MLN9708
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
One-Year Progression-Free Survival at the Recommend Phase II Dose (RP2D)
|
34 Percentage of Participants (%)
Interval 16.0 to 53.0
|
—
|
Adverse Events
Dose Level #1 (3mg MLN9708)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 4 deaths
Dose Level #2 (4mg MLN9708)
Serious events: 11 serious events
Other events: 25 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Dose Level #1 (3mg MLN9708)
n=7 participants at risk
Patients receive 3mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ixazomib citrate: Given orally
dexamethasone: Given orally
pomalidomide: Given orally
|
Dose Level #2 (4mg MLN9708)
n=25 participants at risk
Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ixazomib citrate: Given orally
dexamethasone: Given orally
pomalidomide: Given orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Skin infection
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Lung infection
|
28.6%
2/7 • Number of events 2 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 4 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
General disorders
Death NOS
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
General disorders
Fever
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
Other adverse events
| Measure |
Dose Level #1 (3mg MLN9708)
n=7 participants at risk
Patients receive 3mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ixazomib citrate: Given orally
dexamethasone: Given orally
pomalidomide: Given orally
|
Dose Level #2 (4mg MLN9708)
n=25 participants at risk
Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ixazomib citrate: Given orally
dexamethasone: Given orally
pomalidomide: Given orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
85.7%
6/7 • Number of events 17 • From the date of the first dose up to 2 years
|
76.0%
19/25 • Number of events 88 • From the date of the first dose up to 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
1/7 • Number of events 8 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 4 • From the date of the first dose up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
28.6%
2/7 • Number of events 5 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Eye disorders
Blurred vision
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 24 • From the date of the first dose up to 2 years
|
|
Eye disorders
Cataract
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 11 • From the date of the first dose up to 2 years
|
|
Eye disorders
Eye pain
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Eye disorders
Photophobia
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 13 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 2 • From the date of the first dose up to 2 years
|
40.0%
10/25 • Number of events 35 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
4/7 • Number of events 4 • From the date of the first dose up to 2 years
|
36.0%
9/25 • Number of events 20 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
2/7 • Number of events 4 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 3 • From the date of the first dose up to 2 years
|
16.0%
4/25 • Number of events 8 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 8 • From the date of the first dose up to 2 years
|
40.0%
10/25 • Number of events 26 • From the date of the first dose up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Number of events 4 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 9 • From the date of the first dose up to 2 years
|
|
General disorders
Chills
|
28.6%
2/7 • Number of events 3 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
General disorders
Edema face
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
General disorders
Edema limbs
|
28.6%
2/7 • Number of events 3 • From the date of the first dose up to 2 years
|
24.0%
6/25 • Number of events 22 • From the date of the first dose up to 2 years
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 10 • From the date of the first dose up to 2 years
|
60.0%
15/25 • Number of events 79 • From the date of the first dose up to 2 years
|
|
General disorders
Fever
|
42.9%
3/7 • Number of events 6 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 6 • From the date of the first dose up to 2 years
|
|
General disorders
Flu like symptoms
|
28.6%
2/7 • Number of events 4 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
General disorders
Gait disturbance
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
General disorders
Localized edema
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
General disorders
Malaise
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 4 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Bronchial infection
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 5 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Lung infection
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Nail infection
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Otitis media
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
28.0%
7/25 • Number of events 12 • From the date of the first dose up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
14.3%
1/7 • Number of events 4 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 5 • From the date of the first dose up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 7 • From the date of the first dose up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
3/7 • Number of events 8 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 17 • From the date of the first dose up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
3/7 • Number of events 12 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 4 • From the date of the first dose up to 2 years
|
|
Investigations
Blood bilirubin increased
|
42.9%
3/7 • Number of events 5 • From the date of the first dose up to 2 years
|
16.0%
4/25 • Number of events 13 • From the date of the first dose up to 2 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Investigations
Creatinine increased
|
57.1%
4/7 • Number of events 11 • From the date of the first dose up to 2 years
|
16.0%
4/25 • Number of events 21 • From the date of the first dose up to 2 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Investigations
INR increased
|
14.3%
1/7 • Number of events 20 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
85.7%
6/7 • Number of events 24 • From the date of the first dose up to 2 years
|
52.0%
13/25 • Number of events 46 • From the date of the first dose up to 2 years
|
|
Investigations
Neutrophil count decreased
|
71.4%
5/7 • Number of events 39 • From the date of the first dose up to 2 years
|
68.0%
17/25 • Number of events 105 • From the date of the first dose up to 2 years
|
|
Investigations
Platelet count decreased
|
71.4%
5/7 • Number of events 43 • From the date of the first dose up to 2 years
|
76.0%
19/25 • Number of events 95 • From the date of the first dose up to 2 years
|
|
Investigations
Weight gain
|
28.6%
2/7 • Number of events 22 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 10 • From the date of the first dose up to 2 years
|
|
Investigations
Weight loss
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Investigations
White blood cell decreased
|
85.7%
6/7 • Number of events 40 • From the date of the first dose up to 2 years
|
64.0%
16/25 • Number of events 83 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Acidosis
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Alkalosis
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 4 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 4 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 5 • From the date of the first dose up to 2 years
|
44.0%
11/25 • Number of events 20 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
28.6%
2/7 • Number of events 3 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
28.6%
2/7 • Number of events 2 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
57.1%
4/7 • Number of events 6 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 17 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
42.9%
3/7 • Number of events 11 • From the date of the first dose up to 2 years
|
24.0%
6/25 • Number of events 16 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.3%
1/7 • Number of events 13 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 9 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
42.9%
3/7 • Number of events 6 • From the date of the first dose up to 2 years
|
16.0%
4/25 • Number of events 15 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
57.1%
4/7 • Number of events 10 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 21 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
28.6%
2/7 • Number of events 4 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Obesity
|
28.6%
2/7 • Number of events 20 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 13 • From the date of the first dose up to 2 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
42.9%
3/7 • Number of events 5 • From the date of the first dose up to 2 years
|
32.0%
8/25 • Number of events 14 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
1/7 • Number of events 3 • From the date of the first dose up to 2 years
|
24.0%
6/25 • Number of events 34 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 5 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 17 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 29 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.6%
2/7 • Number of events 7 • From the date of the first dose up to 2 years
|
28.0%
7/25 • Number of events 12 • From the date of the first dose up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Amnesia
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 15 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Dizziness
|
42.9%
3/7 • Number of events 5 • From the date of the first dose up to 2 years
|
32.0%
8/25 • Number of events 15 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 3 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 6 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 4 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Neuralgia
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
57.1%
4/7 • Number of events 20 • From the date of the first dose up to 2 years
|
48.0%
12/25 • Number of events 59 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 7 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • Number of events 12 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 17 • From the date of the first dose up to 2 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 7 • From the date of the first dose up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 36 • From the date of the first dose up to 2 years
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 12 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 17 • From the date of the first dose up to 2 years
|
|
Psychiatric disorders
Mania
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
14.3%
1/7 • Number of events 5 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 6 • From the date of the first dose up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Renal and urinary disorders
Proteinuria
|
71.4%
5/7 • Number of events 50 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 37 • From the date of the first dose up to 2 years
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 2 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 2 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 10 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
3/7 • Number of events 5 • From the date of the first dose up to 2 years
|
24.0%
6/25 • Number of events 45 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
12.0%
3/25 • Number of events 5 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
28.6%
2/7 • Number of events 2 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
16.0%
4/25 • Number of events 6 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
28.6%
2/7 • Number of events 3 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 3 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
4.0%
1/25 • Number of events 1 • From the date of the first dose up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
28.6%
2/7 • Number of events 2 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
2/7 • Number of events 3 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 14 • From the date of the first dose up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
8.0%
2/25 • Number of events 4 • From the date of the first dose up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
42.9%
3/7 • Number of events 4 • From the date of the first dose up to 2 years
|
24.0%
6/25 • Number of events 16 • From the date of the first dose up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.6%
2/7 • Number of events 3 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 6 • From the date of the first dose up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
14.3%
1/7 • Number of events 2 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 16 • From the date of the first dose up to 2 years
|
|
Vascular disorders
Hot flashes
|
14.3%
1/7 • Number of events 1 • From the date of the first dose up to 2 years
|
0.00%
0/25 • From the date of the first dose up to 2 years
|
|
Vascular disorders
Hypertension
|
57.1%
4/7 • Number of events 122 • From the date of the first dose up to 2 years
|
28.0%
7/25 • Number of events 42 • From the date of the first dose up to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • From the date of the first dose up to 2 years
|
20.0%
5/25 • Number of events 7 • From the date of the first dose up to 2 years
|
Additional Information
Dr. Amrita Krishnan
City of Hope National Medical Center
Phone: 626-256-4673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place