Trial Outcomes & Findings for Trial to Assess Chelation Therapy 2 (NCT NCT02733185)
NCT ID: NCT02733185
Last Updated: 2025-03-30
Results Overview
Time to first event: myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or death from any cause
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1000 participants
Primary outcome timeframe
48 month follow-up (median)
Results posted on
2025-03-30
Participant Flow
A total of 1,000 patients were enrolled at 88 clinical centers from United States (83) and Canada (5). The first patient was enrolled on October 18, 2017 and the last patient on December 31, 2020. Each patient was randomly assigned to 1 of the 4 treatment groups.
Participant milestones
| Measure |
Active/Active
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Active/Placebo
Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
Placebo/ Active
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Placebo/Placebo
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
250
|
249
|
250
|
251
|
|
Overall Study
COMPLETED
|
175
|
187
|
182
|
176
|
|
Overall Study
NOT COMPLETED
|
75
|
62
|
68
|
75
|
Reasons for withdrawal
| Measure |
Active/Active
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Active/Placebo
Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
Placebo/ Active
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Placebo/Placebo
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
10
|
17
|
21
|
|
Overall Study
Death
|
46
|
34
|
35
|
43
|
|
Overall Study
Lost to Follow-up
|
17
|
18
|
16
|
11
|
Baseline Characteristics
Trial to Assess Chelation Therapy 2
Baseline characteristics by cohort
| Measure |
Active/Active
n=250 Participants
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Active/Placebo
n=249 Participants
Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
|
Placebo/ Active
n=250 Participants
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
|
Placebo/Placebo
n=251 Participants
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
67 years
n=107 Participants
|
67 years
n=206 Participants
|
67 years
n=7 Participants
|
67 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
270 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
189 Participants
n=99 Participants
|
170 Participants
n=107 Participants
|
175 Participants
n=206 Participants
|
196 Participants
n=7 Participants
|
730 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
198 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
200 Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
201 Participants
n=7 Participants
|
789 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
101 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
186 Participants
n=99 Participants
|
194 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
194 Participants
n=7 Participants
|
778 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
|
Region of Enrollment
North America
|
250 participants
n=99 Participants
|
249 participants
n=107 Participants
|
250 participants
n=206 Participants
|
251 participants
n=7 Participants
|
1000 participants
n=31 Participants
|
|
Type II Diabetes
|
239 Participants
n=99 Participants
|
242 Participants
n=107 Participants
|
235 Participants
n=206 Participants
|
244 Participants
n=7 Participants
|
960 Participants
n=31 Participants
|
|
Time from diabetes diagnosis to randomization
|
13 years
n=99 Participants
|
15 years
n=107 Participants
|
15 years
n=206 Participants
|
14 years
n=7 Participants
|
14 years
n=31 Participants
|
|
Time from qualifying MI to randomization
|
5 years
n=99 Participants
|
5 years
n=107 Participants
|
5 years
n=206 Participants
|
5 years
n=7 Participants
|
5 years
n=31 Participants
|
|
Anterior MI location
|
71 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
310 Participants
n=31 Participants
|
|
Prior coronary revascularization
|
209 Participants
n=99 Participants
|
198 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
207 Participants
n=7 Participants
|
813 Participants
n=31 Participants
|
|
Aspirin, warfarin, or P2Y12 inhibitor
|
223 Participants
n=99 Participants
|
224 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
225 Participants
n=7 Participants
|
897 Participants
n=31 Participants
|
|
Statin
|
210 Participants
n=99 Participants
|
220 Participants
n=107 Participants
|
201 Participants
n=206 Participants
|
221 Participants
n=7 Participants
|
852 Participants
n=31 Participants
|
|
Hemoglobin A1c
|
7.3 %
n=99 Participants
|
7.1 %
n=107 Participants
|
7.3 %
n=206 Participants
|
7.3 %
n=7 Participants
|
7.2 %
n=31 Participants
|
|
HDL
|
41.0 mg/dL
n=99 Participants
|
41.0 mg/dL
n=107 Participants
|
42.0 mg/dL
n=206 Participants
|
40.0 mg/dL
n=7 Participants
|
41 mg/dL
n=31 Participants
|
|
LDL
|
75.0 mg/dL
n=99 Participants
|
72.0 mg/dL
n=107 Participants
|
69.0 mg/dL
n=206 Participants
|
73.0 mg/dL
n=7 Participants
|
73 mg/dL
n=31 Participants
|
|
Triglycerides
|
150.0 mg/dL
n=99 Participants
|
134.0 mg/dL
n=107 Participants
|
139.0 mg/dL
n=206 Participants
|
149.0 mg/dL
n=7 Participants
|
144.0 mg/dL
n=31 Participants
|
|
Lead (blood)
|
9.80 mcg/L
n=99 Participants
|
8.40 mcg/L
n=107 Participants
|
9.50 mcg/L
n=206 Participants
|
9.20 mcg/L
n=7 Participants
|
9.2 mcg/L
n=31 Participants
|
|
Cadmium (urine)
|
0.27 mcg/g
n=99 Participants
|
0.33 mcg/g
n=107 Participants
|
0.30 mcg/g
n=206 Participants
|
0.28 mcg/g
n=7 Participants
|
0.30 mcg/g
n=31 Participants
|
PRIMARY outcome
Timeframe: 48 month follow-up (median)Time to first event: myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or death from any cause
Outcome measures
| Measure |
Active/Active
n=250 Participants
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Active/Placebo
n=249 Participants
Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
|
Placebo/ Active
n=250 Participants
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
|
Placebo/Placebo
n=251 Participants
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
|---|---|---|---|---|
|
Primary Composite Outcome
|
85 Participants
|
89 Participants
|
90 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: 48 month follow-up (median)Time to first event: myocardial infarction, stroke, or death from cardiovascular causes
Outcome measures
| Measure |
Active/Active
n=250 Participants
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Active/Placebo
n=249 Participants
Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
|
Placebo/ Active
n=250 Participants
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
|
Placebo/Placebo
n=251 Participants
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
|---|---|---|---|---|
|
Secondary Composite Outcome
|
50 Participants
|
40 Participants
|
55 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: All-Cause Mortality was assessed through study completion, up to 48 months (median)Time to All-Cause mortality
Outcome measures
| Measure |
Active/Active
n=250 Participants
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Active/Placebo
n=249 Participants
Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
|
Placebo/ Active
n=250 Participants
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
|
Placebo/Placebo
n=251 Participants
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
|---|---|---|---|---|
|
Secondary Outcome
|
50 Participants
|
36 Participants
|
40 Participants
|
49 Participants
|
Adverse Events
Active EDTA/Active Vitamins
Serious events: 41 serious events
Other events: 0 other events
Deaths: 50 deaths
Active EDTA /Placebo Vitamins
Serious events: 40 serious events
Other events: 0 other events
Deaths: 36 deaths
Placebo EDTA/ Active Vitamins
Serious events: 40 serious events
Other events: 0 other events
Deaths: 40 deaths
Placebo EDTA/Placebo Vitamins
Serious events: 40 serious events
Other events: 0 other events
Deaths: 49 deaths
Serious adverse events
| Measure |
Active EDTA/Active Vitamins
n=250 participants at risk
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Active EDTA /Placebo Vitamins
n=249 participants at risk
Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
Placebo EDTA/ Active Vitamins
n=250 participants at risk
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
|
Placebo EDTA/Placebo Vitamins
n=251 participants at risk
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Placebo disodium EDTA
Placebo Oral Multi Vitamins/Minerals (OMVM)
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
2.8%
7/250 • Number of events 7 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
6.0%
15/249 • Number of events 19 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
4.4%
11/250 • Number of events 13 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
6.0%
15/251 • Number of events 22 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Infections and infestations
Infections and infestations
|
4.0%
10/250 • Number of events 11 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
3.2%
8/249 • Number of events 10 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
6.8%
17/250 • Number of events 18 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
5.6%
14/251 • Number of events 14 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
2.4%
6/250 • Number of events 8 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
1.2%
3/249 • Number of events 4 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/250 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
1.2%
3/251 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Nervous system disorders
Nervous System Disorders
|
2.4%
6/250 • Number of events 7 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.00%
0/249 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
1.2%
3/250 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
2.4%
6/251 • Number of events 6 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
1.2%
3/250 • Number of events 6 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
2.0%
5/249 • Number of events 6 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/250 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.40%
1/251 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
General disorders
General disorders and administration site conditions
|
1.6%
4/250 • Number of events 4 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
1.6%
4/249 • Number of events 4 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/250 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.40%
1/251 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
1.6%
4/250 • Number of events 5 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
2.0%
5/249 • Number of events 5 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.40%
1/250 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.00%
0/251 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.80%
2/250 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/249 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
1.2%
3/250 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/251 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Vascular disorders
Vascular disorders
|
0.80%
2/250 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/249 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.40%
1/250 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
1.6%
4/251 • Number of events 4 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
1.2%
3/250 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
1.2%
3/249 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/250 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.40%
1/251 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.80%
2/250 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/249 • Number of events 4 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/250 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.00%
0/251 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Psychiatric disorders
Psychiatric disorders
|
0.80%
2/250 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.00%
0/249 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
1.2%
3/250 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.40%
1/251 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.40%
1/250 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.40%
1/249 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.40%
1/250 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/251 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/250 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/249 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.00%
0/250 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/251 • Number of events 2 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.00%
0/250 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.40%
1/249 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.80%
2/250 • Number of events 3 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.00%
0/251 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.40%
1/250 • Number of events 1 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.00%
0/249 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.00%
0/250 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
0.00%
0/251 • All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gervasio Lamas
Mount Sinai Medical Center of Florida
Phone: 305-674-2162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place