Trial Outcomes & Findings for Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy (NCT NCT03080883)
NCT ID: NCT03080883
Last Updated: 2025-05-18
Results Overview
Incidence of major bleeding and clinically relevant non-major bleeding will be estimated using the cumulative incidence function (CIF) with death without major bleeding or clinically relevant non-major bleeding and with adverse events that results in termination of treatment (including vascular events) as competing risks. The time to event is defined as the time from randomization to the first occurrence of a major bleeding, a clinically relevant non-major bleeding, death without major bleeding or clinically relevant non-major bleeding, or an adverse event that results in termination of treatment. Patients who were lost to follow-up, who withdrew informed consent before the end of the predefined study duration will be censored at the last day the patient had a complete assessment for study outcomes within the intended study period. The difference in the incidences of the combined endpoint at 12 months between treatment arms will be estimated along with a 95% confidence interval
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
370 participants
Primary outcome timeframe
12 months
Results posted on
2025-05-18
Participant Flow
5 patients enrolled in arm 1 and 5 patients enrolled in arm 2 did not begin treatment and therefore are not included in the participant flow table.
Participant milestones
| Measure |
Group I (2.5mg Dose Apixaban)
Patients receive lower dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
Group II (5mg Dose Apixaban)
Patients receive higher dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
179
|
181
|
|
Overall Study
COMPLETED
|
111
|
109
|
|
Overall Study
NOT COMPLETED
|
68
|
72
|
Reasons for withdrawal
| Measure |
Group I (2.5mg Dose Apixaban)
Patients receive lower dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
Group II (5mg Dose Apixaban)
Patients receive higher dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
15
|
|
Overall Study
Adverse Event
|
22
|
22
|
|
Overall Study
Alternative Therapy
|
0
|
3
|
|
Overall Study
Other Complicating Disease
|
9
|
5
|
|
Overall Study
Death
|
21
|
16
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Disease Progression
|
2
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy
Baseline characteristics by cohort
| Measure |
Group I (2.5mg Dose Apixaban)
n=179 Participants
Patients receive lower dose apixaban PO BID for 365 days.\>
\> Apixaban: Given PO
|
Group II (5mg Dose Apixaban)
n=181 Participants
Patients receive higher dose apixaban PO BID for 365 days.\>
\> Apixaban: Given PO
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 10.96 • n=93 Participants
|
64.3 years
STANDARD_DEVIATION 10.72 • n=4 Participants
|
64.0 years
STANDARD_DEVIATION 10.83 • n=27 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
199 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
161 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
171 Participants
n=93 Participants
|
176 Participants
n=4 Participants
|
347 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
168 Participants
n=93 Participants
|
169 Participants
n=4 Participants
|
337 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
179 participants
n=93 Participants
|
181 participants
n=4 Participants
|
360 participants
n=27 Participants
|
|
Primary Tumor Site
Brain/CNS
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Primary Tumor Site
Breast
|
10 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Primary Tumor Site
Colon/rectum/pancreas/stomach
|
44 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Primary Tumor Site
ENT
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Primary Tumor Site
Genitourinary
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Primary Tumor Site
Gynecologic
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Primary Tumor Site
Kidney/bladder
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Primary Tumor Site
Liver/bile duct
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Primary Tumor Site
Lung/bronchus
|
26 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Primary Tumor Site
Lymphoma/Myeloma/Leukemia
|
34 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Primary Tumor Site
Melanoma
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Primary Tumor Site
Other
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Primary Tumor Site
Prostate
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Primary Tumor Site
Sarcoma
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Primary Tumor Site
Skin
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Primary Tumor Site
Thyroid
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Primary Tumor Site
Tongue/mouth/pharynx
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Primary Tumor Site
Upper Gastrointestinal
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Primary Tumor Site
Uterine cervix/corpus
|
8 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
ECOG Performance Status
0
|
97 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
193 Participants
n=27 Participants
|
|
ECOG Performance Status
1
|
73 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
153 Participants
n=27 Participants
|
|
ECOG Performance Status
2
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Location of Initial Thrombosis
Deep-vein thrombosis (including atypical VTE)
|
82 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
168 Participants
n=27 Participants
|
|
Location of Initial Thrombosis
Pulmonary embolism
|
97 Participants
n=93 Participants
|
95 Participants
n=4 Participants
|
192 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsIncidence of major bleeding and clinically relevant non-major bleeding will be estimated using the cumulative incidence function (CIF) with death without major bleeding or clinically relevant non-major bleeding and with adverse events that results in termination of treatment (including vascular events) as competing risks. The time to event is defined as the time from randomization to the first occurrence of a major bleeding, a clinically relevant non-major bleeding, death without major bleeding or clinically relevant non-major bleeding, or an adverse event that results in termination of treatment. Patients who were lost to follow-up, who withdrew informed consent before the end of the predefined study duration will be censored at the last day the patient had a complete assessment for study outcomes within the intended study period. The difference in the incidences of the combined endpoint at 12 months between treatment arms will be estimated along with a 95% confidence interval
Outcome measures
| Measure |
Group I (2.5mg Dose Apixaban)
n=179 Participants
Patients receive lower dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
Group II (5mg Dose Apixaban)
n=181 Participants
Patients receive higher dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
|---|---|---|
|
CIF of Major or Clinically Relevant Non-major Bleeding Combined With Death as Competing Risk
|
9.6 proportion of participants
Interval 6.0 to 15.4
|
13.5 proportion of participants
Interval 9.1 to 20.0
|
SECONDARY outcome
Timeframe: 6 monthsIncidence of major bleeding and clinically relevant non-major bleeding will be estimated using the cumulative incidence function (CIF) with death without major bleeding or clinically relevant non-major bleeding and with adverse events that results in termination of treatment (including vascular events) as competing risks. The time to event is defined as the time from randomization to the first occurrence of a major bleeding, a clinically relevant non-major bleeding, death without major bleeding or clinically relevant non-major bleeding, or an adverse event that results in termination of treatment. Patients who were lost to follow-up, who withdrew informed consent before the end of the predefined study duration will be censored at the last day the patient had a complete assessment for study outcomes within the intended study period. The difference in the incidences of the combined endpoint at 6 months between treatment arms will be estimated along with a 95% confidence interval.
Outcome measures
| Measure |
Group I (2.5mg Dose Apixaban)
n=179 Participants
Patients receive lower dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
Group II (5mg Dose Apixaban)
n=181 Participants
Patients receive higher dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
|---|---|---|
|
Proportion of Patients Who Experienced at Least One Bleeding Event
|
4.9 proportion of participants
Interval 2.5 to 9.7
|
5.8 proportion of participants
Interval 3.0 to 10.9
|
SECONDARY outcome
Timeframe: 12 monthsFor the secondary outcome analysis, the time from starting treatment to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) outcome will be analyzed using the same method described in the section for primary outcome plan. For this outcome, death without DVT/PE and adverse events leading to termination of treatment will be treated as the competing risks.
Outcome measures
| Measure |
Group I (2.5mg Dose Apixaban)
n=179 Participants
Patients receive lower dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
Group II (5mg Dose Apixaban)
n=181 Participants
Patients receive higher dose apixaban PO BID for 365 days. \>
\> Apixaban: Given PO
|
|---|---|---|
|
Cumulative Incidence Function of DVT/PE Treating Death or AE Resulting in End of Treatment as Competing Risk by Study Arm
|
5.8 proportion of participants
Interval 3.2 to 10.6
|
7.1 proportion of participants
Interval 4.1 to 12.2
|
Adverse Events
Group I (2.5mg Dose Apixaban)
Serious events: 70 serious events
Other events: 93 other events
Deaths: 26 deaths
Group II (5mg Dose Apixaban)
Serious events: 69 serious events
Other events: 75 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Group I (2.5mg Dose Apixaban)
n=179 participants at risk
Apixaban: Given PO
|
Group II (5mg Dose Apixaban)
n=181 participants at risk
Apixaban: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.4%
6/179 • Number of events 6 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
1.1%
2/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.56%
1/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Cardiac disorders
Cardiac arrest
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Cardiac disorders
Chest pain - cardiac
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Cardiac disorders
Heart failure
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
4/179 • Number of events 5 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
2/179 • Number of events 3 • 29 months
|
2.2%
4/181 • Number of events 4 • 29 months
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Gastritis
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
2.2%
4/179 • Number of events 4 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Ileus
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Nausea
|
2.8%
5/179 • Number of events 7 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Pancreatitis
|
1.1%
2/179 • Number of events 3 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.8%
5/179 • Number of events 6 • 29 months
|
3.3%
6/181 • Number of events 7 • 29 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
4/179 • Number of events 5 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
General disorders
Death NOS
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
General disorders
Fatigue
|
1.7%
3/179 • Number of events 3 • 29 months
|
2.2%
4/181 • Number of events 4 • 29 months
|
|
General disorders
Fever
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
General disorders
Non-cardiac chest pain
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
General disorders
Pain
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
General disorders
Sudden death NOS
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
2/179 • Number of events 3 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.1%
2/179 • Number of events 3 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Infections and infestations
Abdominal infection
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Infections and infestations
Bronchial infection
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Infections and infestations
Device related infection
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
3.4%
6/179 • Number of events 7 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Infections and infestations
Lung infection
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
Infections and infestations
Sepsis
|
3.4%
6/179 • Number of events 7 • 29 months
|
5.0%
9/181 • Number of events 11 • 29 months
|
|
Infections and infestations
Skin infection
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Infections and infestations
Upper respiratory infection
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Infections and infestations
Urinary tract infection
|
2.8%
5/179 • Number of events 6 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Injury, poisoning and procedural complications
Fracture
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Injury, poisoning and procedural complications
Urostomy stenosis
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
2/179 • Number of events 3 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
Investigations
Alkaline phosphatase increased
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
3/179 • Number of events 4 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
Investigations
Blood bilirubin increased
|
0.56%
1/179 • Number of events 7 • 29 months
|
0.00%
0/181 • 29 months
|
|
Investigations
Creatinine increased
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Investigations
Ejection fraction decreased
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Investigations
Investigations - Other, specify
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Investigations
Lipase increased
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Investigations
Lymphocyte count decreased
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Investigations
Platelet count decreased
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
3/179 • Number of events 4 • 29 months
|
0.00%
0/181 • 29 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.7%
3/179 • Number of events 4 • 29 months
|
0.00%
0/181 • 29 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.56%
1/179 • Number of events 1 • 29 months
|
2.8%
5/181 • Number of events 5 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
11.7%
21/179 • Number of events 24 • 29 months
|
10.5%
19/181 • Number of events 19 • 29 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Encephalopathy
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Headache
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Nervous system disorders
Stroke
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
Nervous system disorders
Syncope
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Psychiatric disorders
Confusion
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Psychiatric disorders
Delirium
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Renal and urinary disorders
Hematuria
|
3.4%
6/179 • Number of events 7 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Renal and urinary disorders
Proteinuria
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.1%
2/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Renal and urinary disorders
Renal calculi
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Renal and urinary disorders
Urinary incontinence
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Renal and urinary disorders
Urinary retention
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.56%
1/179 • Number of events 1 • 29 months
|
2.2%
4/181 • Number of events 4 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.56%
1/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Vascular disorders
Hematoma
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Vascular disorders
Hypotension
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Vascular disorders
Lymphedema
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Vascular disorders
Thromboembolic event
|
2.2%
4/179 • Number of events 4 • 29 months
|
2.2%
4/181 • Number of events 4 • 29 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
Other adverse events
| Measure |
Group I (2.5mg Dose Apixaban)
n=179 participants at risk
Apixaban: Given PO
|
Group II (5mg Dose Apixaban)
n=181 participants at risk
Apixaban: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.0%
25/179 • Number of events 53 • 29 months
|
12.7%
23/181 • Number of events 39 • 29 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
3.4%
6/179 • Number of events 8 • 29 months
|
3.3%
6/181 • Number of events 6 • 29 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Cardiac disorders
Sinus tachycardia
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.56%
1/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Endocrine disorders
Hypothyroidism
|
0.56%
1/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Eye disorders
Cataract
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Eye disorders
Glaucoma
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Eye disorders
Watering eyes
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
6/179 • Number of events 6 • 29 months
|
1.1%
2/181 • Number of events 3 • 29 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Gastrointestinal disorders
Bloating
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 3 • 29 months
|
|
Gastrointestinal disorders
Constipation
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.1%
2/181 • Number of events 3 • 29 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
6/179 • Number of events 9 • 29 months
|
1.1%
2/181 • Number of events 3 • 29 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
1.1%
2/179 • Number of events 2 • 29 months
|
2.2%
4/181 • Number of events 5 • 29 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Nausea
|
3.4%
6/179 • Number of events 6 • 29 months
|
2.2%
4/181 • Number of events 4 • 29 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.56%
1/179 • Number of events 4 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Rectal pain
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
General disorders
Death NOS
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
General disorders
Edema limbs
|
5.0%
9/179 • Number of events 10 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
General disorders
Fatigue
|
7.8%
14/179 • Number of events 26 • 29 months
|
2.2%
4/181 • Number of events 4 • 29 months
|
|
General disorders
Fever
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.7%
3/179 • Number of events 4 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
General disorders
Localized edema
|
0.56%
1/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
General disorders
Neck edema
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
General disorders
Non-cardiac chest pain
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
General disorders
Pain
|
1.7%
3/179 • Number of events 4 • 29 months
|
0.00%
0/181 • 29 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Immune system disorders
Allergic reaction
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Infections and infestations
Bladder infection
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Infections and infestations
Bronchial infection
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Infections and infestations
Conjunctivitis
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.2%
4/179 • Number of events 5 • 29 months
|
1.7%
3/181 • Number of events 4 • 29 months
|
|
Infections and infestations
Lung infection
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Infections and infestations
Urinary tract infection
|
0.56%
1/179 • Number of events 3 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Injury, poisoning and procedural complications
Bruising
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
4/179 • Number of events 4 • 29 months
|
0.00%
0/181 • 29 months
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
3/179 • Number of events 4 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Investigations
Alkaline phosphatase increased
|
1.7%
3/179 • Number of events 20 • 29 months
|
3.9%
7/181 • Number of events 13 • 29 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
4/179 • Number of events 6 • 29 months
|
2.2%
4/181 • Number of events 4 • 29 months
|
|
Investigations
Blood bilirubin increased
|
0.56%
1/179 • Number of events 2 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Investigations
Cardiac troponin T increased
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Investigations
Creatinine increased
|
2.8%
5/179 • Number of events 20 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
Investigations
INR increased
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Investigations
Investigations - Other, specify
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Investigations
Lymphocyte count decreased
|
10.1%
18/179 • Number of events 58 • 29 months
|
6.1%
11/181 • Number of events 14 • 29 months
|
|
Investigations
Neutrophil count decreased
|
4.5%
8/179 • Number of events 13 • 29 months
|
3.3%
6/181 • Number of events 7 • 29 months
|
|
Investigations
Platelet count decreased
|
6.7%
12/179 • Number of events 19 • 29 months
|
3.9%
7/181 • Number of events 14 • 29 months
|
|
Investigations
Urine output decreased
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Investigations
Weight loss
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Investigations
White blood cell decreased
|
5.6%
10/179 • Number of events 18 • 29 months
|
2.8%
5/181 • Number of events 5 • 29 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.4%
6/179 • Number of events 14 • 29 months
|
2.8%
5/181 • Number of events 9 • 29 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.1%
2/179 • Number of events 4 • 29 months
|
0.00%
0/181 • 29 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.9%
7/179 • Number of events 20 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.1%
2/179 • Number of events 4 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
3/179 • Number of events 6 • 29 months
|
2.2%
4/181 • Number of events 4 • 29 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.1%
2/179 • Number of events 2 • 29 months
|
2.8%
5/181 • Number of events 6 • 29 months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Metabolism and nutrition disorders
Obesity
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.55%
1/181 • Number of events 3 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.7%
3/179 • Number of events 4 • 29 months
|
1.1%
2/181 • Number of events 4 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
3/179 • Number of events 4 • 29 months
|
0.00%
0/181 • 29 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.56%
1/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Dizziness
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 3 • 29 months
|
|
Nervous system disorders
Dysgeusia
|
0.56%
1/179 • Number of events 2 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Headache
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.00%
0/181 • 29 months
|
|
Nervous system disorders
Memory impairment
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
4/179 • Number of events 4 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Somnolence
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Nervous system disorders
Syncope
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Psychiatric disorders
Confusion
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.7%
3/181 • Number of events 3 • 29 months
|
|
Psychiatric disorders
Delirium
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.2%
4/179 • Number of events 8 • 29 months
|
1.7%
3/181 • Number of events 7 • 29 months
|
|
Renal and urinary disorders
Hematuria
|
2.8%
5/179 • Number of events 5 • 29 months
|
4.4%
8/181 • Number of events 8 • 29 months
|
|
Renal and urinary disorders
Proteinuria
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.00%
0/179 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 2 • 29 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
8/179 • Number of events 8 • 29 months
|
3.9%
7/181 • Number of events 10 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
8/179 • Number of events 8 • 29 months
|
1.7%
3/181 • Number of events 4 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
4/179 • Number of events 4 • 29 months
|
2.8%
5/181 • Number of events 6 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 3 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.1%
2/179 • Number of events 2 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.56%
1/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.00%
0/181 • 29 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.56%
1/179 • Number of events 1 • 29 months
|
1.1%
2/181 • Number of events 2 • 29 months
|
|
Vascular disorders
Hot flashes
|
0.00%
0/179 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Vascular disorders
Hypertension
|
6.7%
12/179 • Number of events 13 • 29 months
|
2.8%
5/181 • Number of events 5 • 29 months
|
|
Vascular disorders
Hypotension
|
0.56%
1/179 • Number of events 1 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Vascular disorders
Thromboembolic event
|
1.7%
3/179 • Number of events 3 • 29 months
|
0.55%
1/181 • Number of events 1 • 29 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.1%
2/179 • Number of events 2 • 29 months
|
0.00%
0/181 • 29 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place