Trial Outcomes & Findings for Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia (NCT NCT01522976)
NCT ID: NCT01522976
Last Updated: 2025-11-26
Results Overview
A response is any of complete hematological remission, partial remission, or hematologic improvement.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
282 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2025-11-26
Participant Flow
Participant milestones
| Measure |
Arm 1: Azacitidine/Lenalidomide
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Lenalidomide: Given PO
|
Arm 2: Azacitidine
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
|
Arm 3: Azacitidine/Vorinostat
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
97
|
92
|
93
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
97
|
92
|
93
|
Reasons for withdrawal
| Measure |
Arm 1: Azacitidine/Lenalidomide
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Lenalidomide: Given PO
|
Arm 2: Azacitidine
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
|
Arm 3: Azacitidine/Vorinostat
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO
|
|---|---|---|---|
|
Overall Study
Ineligible
|
4
|
0
|
1
|
|
Overall Study
Death
|
7
|
6
|
2
|
|
Overall Study
Still on treatment
|
9
|
9
|
6
|
|
Overall Study
Disease progression
|
28
|
30
|
25
|
|
Overall Study
Adverse Event
|
17
|
7
|
18
|
|
Overall Study
Refusal unrelated to adverse event
|
10
|
13
|
14
|
|
Overall Study
Not protocol specified
|
22
|
27
|
27
|
Baseline Characteristics
Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
Baseline characteristics by cohort
| Measure |
Arm 1: Azacitidine/Lenalidomide
n=93 Participants
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Lenalidomide: Given PO
|
Arm 2: Azacitidine
n=92 Participants
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
|
Arm 3: Azacitidine/Vorinostat
n=92 Participants
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO
|
Total
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.81 years
n=492 Participants
|
69.67 years
n=492 Participants
|
70.36 years
n=984 Participants
|
70.18 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=492 Participants
|
31 Participants
n=492 Participants
|
22 Participants
n=984 Participants
|
85 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=492 Participants
|
61 Participants
n=492 Participants
|
70 Participants
n=984 Participants
|
192 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=492 Participants
|
4 Participants
n=492 Participants
|
2 Participants
n=984 Participants
|
7 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=492 Participants
|
3 Participants
n=492 Participants
|
4 Participants
n=984 Participants
|
9 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=492 Participants
|
80 Participants
n=492 Participants
|
83 Participants
n=984 Participants
|
249 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=492 Participants
|
5 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
9 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Analysis includes eligible patients only.
A response is any of complete hematological remission, partial remission, or hematologic improvement.
Outcome measures
| Measure |
Arm 3: Azacitidine/Vorinostat
n=92 Participants
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO
|
Arm 1: Azacitidine/Lenalidomide
n=93 Participants
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
Arm 2: Azacitidine
n=92 Participants
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
|---|---|---|---|
|
Response Rate (Phase II)
|
27 percentage of patients having a response
Interval 18.0 to 37.0
|
49 percentage of patients having a response
Interval 39.0 to 60.0
|
38 percentage of patients having a response
Interval 28.0 to 49.0
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: This trial did not proceed to the Phase III portion. Therefore, no patients were analyzed for this outcome measure.
OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow-up for patients last known to be alive is censored at the date of last contact. Stratified Cox regression models will be used to compare OS of the combination arm selected in the Phase II portion of the trial to OS of the single-agent azacitidine arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Analysis includes eligible patients who had a response.
RFS is calculated for patients who have achieved a response. RFS will be measured from the date of response to the date of first documentation of relapse from response (as defined in the primary objective), or death due to any cause. The follow-up for patients last known to be alive and without report of relapse is censored at the date of last contact. RFS will be estimated for each of the three arms using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm 3: Azacitidine/Vorinostat
n=25 Participants
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO
|
Arm 1: Azacitidine/Lenalidomide
n=46 Participants
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
Arm 2: Azacitidine
n=35 Participants
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
|---|---|---|---|
|
Relapse-free Survival
|
455 Days
Interval 197.0 to
The upper limit of the confidence interval cannot be estimated.
|
435 Days
Interval 237.0 to 546.0
|
311 Days
Interval 182.0 to 640.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Analysis includes eligible patients only.
OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow- up for patients last known to be alive is censored at the date of last contact. OS will be estimated for each of the three arms using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm 3: Azacitidine/Vorinostat
n=92 Participants
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO
|
Arm 1: Azacitidine/Lenalidomide
n=93 Participants
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
Arm 2: Azacitidine
n=92 Participants
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
|---|---|---|---|
|
Overall Survival
|
527 Days
Interval 392.0 to 852.0
|
588 Days
Interval 426.0 to 737.0
|
449 Days
Interval 356.0 to 603.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Analysis includes eligible patients only.
Cytogenetic risk group is used to identify cytogenetic abnormalities.
Outcome measures
| Measure |
Arm 3: Azacitidine/Vorinostat
n=92 Participants
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO
|
Arm 1: Azacitidine/Lenalidomide
n=93 Participants
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
Arm 2: Azacitidine
n=92 Participants
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
|---|---|---|---|
|
Pre-study Cytogenetic Abnormalities
Good/very good
|
34 participants
|
35 participants
|
29 participants
|
|
Pre-study Cytogenetic Abnormalities
Intermediate
|
18 participants
|
13 participants
|
16 participants
|
|
Pre-study Cytogenetic Abnormalities
Poor
|
8 participants
|
8 participants
|
10 participants
|
|
Pre-study Cytogenetic Abnormalities
Very poor
|
19 participants
|
23 participants
|
23 participants
|
|
Pre-study Cytogenetic Abnormalities
Missing
|
13 participants
|
14 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Analysis includes only eligible patients who also received treatment.
Adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm 3: Azacitidine/Vorinostat
n=91 Participants
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO
|
Arm 1: Azacitidine/Lenalidomide
n=89 Participants
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
Arm 2: Azacitidine
n=91 Participants
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
|---|---|---|---|
|
Toxicity Rate
Abdominal infection
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Abdominal pain
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Acute kidney injury
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Adult respiratory distress syndrome
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Alanine aminotransferase increased
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Anemia
|
44 Participants
|
48 Participants
|
37 Participants
|
|
Toxicity Rate
Anorectal infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Anorexia
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Toxicity Rate
Apnea
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Ascites
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Aspartate aminotransferase increased
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Ataxia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Back pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Blood and lymphatic system disorders - Other
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Toxicity Rate
Blood bilirubin increased
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Bronchial infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
CD4 lymphocytes decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Cardiac arrest
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Catheter related infection
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Toxicity Rate
Cecal infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Cholecystitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Colitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Confusion
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Constipation
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Toxicity Rate
Creatinine increased
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Toxicity Rate
Dehydration
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Toxicity Rate
Delirium
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Diarrhea
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Toxicity Rate
Dizziness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Dyspnea
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Toxicity Rate
Epistaxis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Esophageal pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Esophagitis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Fall
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Fatigue
|
14 Participants
|
9 Participants
|
6 Participants
|
|
Toxicity Rate
Febrile neutropenia
|
13 Participants
|
16 Participants
|
11 Participants
|
|
Toxicity Rate
Fever
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Flushing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Gastric hemorrhage
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Gastrointestinal pain
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
General disorders and admin site conditions-Other
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Generalized muscle weakness
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Toxicity Rate
Hallucinations
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Headache
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Heart failure
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Hematoma
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Hematuria
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Hyperglycemia
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Toxicity Rate
Hypernatremia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity Rate
Hypertension
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Hyperuricemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Hypoalbuminemia
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Toxicity Rate
Hypokalemia
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Toxicity Rate
Hypomagnesemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Hyponatremia
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Toxicity Rate
Hypophosphatemia
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Hypotension
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Toxicity Rate
Hypoxia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Infections and infestations - Other, specify
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Toxicity Rate
Intracranial hemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Investigations - Other, specify
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Leukocytosis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity Rate
Lower gastrointestinal hemorrhage
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Lung infection
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Toxicity Rate
Lymphocyte count decreased
|
3 Participants
|
14 Participants
|
9 Participants
|
|
Toxicity Rate
Lymphocyte count increased
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity Rate
Mucosal infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Mucositis oral
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Nausea
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Toxicity Rate
Neutrophil count decreased
|
63 Participants
|
69 Participants
|
48 Participants
|
|
Toxicity Rate
Pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Papulopustular rash
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Pericardial effusion
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Platelet count decreased
|
64 Participants
|
61 Participants
|
46 Participants
|
|
Toxicity Rate
Pneumonitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Pruritus
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Pulmonary edema
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Purpura
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Rash maculo-papular
|
1 Participants
|
13 Participants
|
3 Participants
|
|
Toxicity Rate
Renal and urinary disorders - Other, specify
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Respiratory failure
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Sepsis
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Toxicity Rate
Sinus bradycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Skin infection
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Toxicity Rate
Soft tissue infection
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Toxicity Rate
Sudden death NOS
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity Rate
Syncope
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Toxicity Rate
Thromboembolic event
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
Tooth infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Upper gastrointestinal hemorrhage
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Upper respiratory infection
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity Rate
Urinary tract infection
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Toxicity Rate
Vascular disorders - Other, specify
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Rate
Vomiting
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Toxicity Rate
Weight loss
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Rate
White blood cell decreased
|
44 Participants
|
48 Participants
|
34 Participants
|
Adverse Events
Arm 1: Azacitidine/Lenalidomide
Serious events: 37 serious events
Other events: 88 other events
Deaths: 0 deaths
Arm 2: Azacitidine
Serious events: 8 serious events
Other events: 89 other events
Deaths: 0 deaths
Arm 3: Azacitidine/Vorinostat
Serious events: 47 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Azacitidine/Lenalidomide
n=89 participants at risk
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
|
Arm 2: Azacitidine
n=91 participants at risk
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
Arm 3: Azacitidine/Vorinostat
n=91 participants at risk
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Ascites
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
6/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
6/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Heart failure
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Sinus bradycardia
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Fever
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Ileus
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Jejunal hemorrhage
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Death NOS
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Edema limbs
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Fatigue
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Infusion related reaction
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Malaise
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Pain
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Sudden death NOS
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Hepatobiliary disorders
Hepatobiliary disorders-Other
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Immune system disorders
Allergic reaction
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Abdominal infection
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Infections and infestations-Other
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
8.8%
8/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Lip infection
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Lung infection
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Sepsis
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Skin infection
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Soft tissue infection
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Blood bilirubin increased
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Cardiac troponin I increased
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Creatinine increased
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Investigations-Other
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Neutrophil count decreased
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Platelet count decreased
|
7.9%
7/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
8.8%
8/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
White blood cell decreased
|
3.4%
3/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
3/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Dizziness
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Headache
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Nervous system disorders-Other
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Presyncope
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Stroke
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Syncope
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Confusion
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Hematuria
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Renal calculi
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
6/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Flushing
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hematoma
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hypertension
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hypotension
|
3.4%
3/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Thromboembolic event
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Vascular disorders-Other
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
Other adverse events
| Measure |
Arm 1: Azacitidine/Lenalidomide
n=89 participants at risk
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
|
Arm 2: Azacitidine
n=91 participants at risk
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
Arm 3: Azacitidine/Vorinostat
n=91 participants at risk
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury, poison and procedural complications - Other
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
0.00%
0/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Alanine aminotransferase increased
|
20.2%
18/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
17.6%
16/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
18.7%
17/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Alkaline phosphatase increased
|
19.1%
17/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
17.6%
16/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
14.3%
13/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Aspartate aminotransferase increased
|
20.2%
18/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
25.3%
23/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
18.7%
17/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Blood bilirubin increased
|
15.7%
14/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
14.3%
13/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
26.4%
24/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Creatinine increased
|
23.6%
21/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
28.6%
26/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
27.5%
25/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
INR increased
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Lymphocyte count decreased
|
36.0%
32/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
17.6%
16/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
20.9%
19/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Neutrophil count decreased
|
86.5%
77/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
63.7%
58/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
80.2%
73/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Platelet count decreased
|
87.6%
78/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
74.7%
68/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
75.8%
69/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Weight loss
|
24.7%
22/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
16.5%
15/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
20.9%
19/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
White blood cell decreased
|
74.2%
66/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
57.1%
52/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
65.9%
60/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
43.8%
39/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
34.1%
31/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
49.5%
45/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.1%
9/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
11.0%
10/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
18.7%
17/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.1%
33/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
29.7%
27/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
35.2%
32/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
6/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.4%
3/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.6%
29/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
23.1%
21/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
35.2%
32/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.7%
30/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
17.6%
16/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
27.5%
25/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
44.9%
40/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
16.5%
15/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
20.9%
19/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.6%
13/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
11.0%
10/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
9.9%
9/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.8%
23/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
24.2%
22/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
37.4%
34/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.9%
15/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
12.1%
11/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.0%
16/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
19.8%
18/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
15.4%
14/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
6/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
24.7%
22/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
16.5%
15/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
25.3%
23/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.0%
16/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
13.2%
12/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
6/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
21.3%
19/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
17.6%
16/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
13.2%
12/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Dizziness
|
21.3%
19/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
24.2%
22/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
30.8%
28/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Dysgeusia
|
12.4%
11/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
12.1%
11/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
17.6%
16/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Headache
|
13.5%
12/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
15.4%
14/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
17.6%
16/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Paresthesia
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.1%
9/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
11.0%
10/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
8.8%
8/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Tremor
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Anxiety
|
16.9%
15/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
14.3%
13/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Confusion
|
3.4%
3/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Depression
|
10.1%
9/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
9.9%
9/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
13.2%
12/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Insomnia
|
20.2%
18/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
16.5%
15/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
15.4%
14/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Proteinuria
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Urinary frequency
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.9%
7/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.0%
24/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
28.6%
26/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
30.8%
28/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
46.1%
41/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
39.6%
36/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
39.6%
36/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
14.3%
13/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
12.1%
11/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.4%
3/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.9%
7/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.9%
7/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
8.8%
8/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
12.1%
11/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.9%
7/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.6%
29/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
16.5%
15/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.7%
6/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
51.7%
46/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
22.0%
20/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
17.6%
16/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
15.7%
14/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
16.5%
15/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hematoma
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hot flashes
|
10.1%
9/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hypertension
|
11.2%
10/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
12.1%
11/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
12.1%
11/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hypotension
|
14.6%
13/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
16.5%
15/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Dry mouth
|
11.2%
10/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
9.9%
9/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
14.3%
13/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.5%
4/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
1.1%
1/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.9%
15/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
11.0%
10/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Nausea
|
42.7%
38/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
46.2%
42/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
67.0%
61/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Vomiting
|
20.2%
18/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
19.8%
18/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
39.6%
36/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Chills
|
21.3%
19/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
12.1%
11/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
11.0%
10/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Edema limbs
|
27.0%
24/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
24.2%
22/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
30.8%
28/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Fatigue
|
83.1%
74/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
75.8%
69/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
81.3%
74/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Fever
|
15.7%
14/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
20.9%
19/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
16.5%
15/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
General disorders and admin site conditions - Other
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Injection site reaction
|
24.7%
22/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
20.9%
19/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
19.8%
18/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Non-cardiac chest pain
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Pain
|
15.7%
14/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
11.0%
10/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
11.0%
10/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Infections and infestations-Other
|
10.1%
9/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
11.0%
10/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
8.8%
8/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Lung infection
|
2.2%
2/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
5.5%
5/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Skin infection
|
10.1%
9/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
14.3%
13/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
9.9%
9/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Upper respiratory infection
|
5.6%
5/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Urinary tract infection
|
9.0%
8/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
3.3%
3/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Injury, poisoning and procedural complications
Bruising
|
28.1%
25/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
26.4%
24/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
19.8%
18/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
7.7%
7/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
Anemia
|
85.4%
76/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
78.0%
71/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
79.1%
72/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.6%
13/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
15.4%
14/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
14.3%
13/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Chest pain - cardiac
|
3.4%
3/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
2.2%
2/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
6.6%
6/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
3/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
4.4%
4/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
9.9%
9/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.0%
8/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
15.4%
14/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
23.1%
21/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Constipation
|
55.1%
49/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
59.3%
54/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
48.4%
44/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
47.2%
42/89 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
25.3%
23/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
58.2%
53/91 • Up to 5 years
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
Additional Information
Leukemia Committee Statistician
SWOG Statistical Center
Phone: 206-667-6597
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60