Trial Outcomes & Findings for Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi (NCT NCT01650558)
NCT ID: NCT01650558
Last Updated: 2022-07-28
Results Overview
Incidence of severe events (composite of death and WHO stage 3 and 4 illness)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1499 participants
Primary outcome timeframe
22-66 months
Results posted on
2022-07-28
Participant Flow
Participant milestones
| Measure |
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
Overall Study
STARTED
|
500
|
500
|
499
|
|
Overall Study
COMPLETED
|
417
|
408
|
424
|
|
Overall Study
NOT COMPLETED
|
83
|
92
|
75
|
Reasons for withdrawal
| Measure |
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
Overall Study
Migration out of study area
|
61
|
71
|
56
|
|
Overall Study
Lost to Follow-up
|
10
|
13
|
6
|
|
Overall Study
Death
|
10
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
|
Overall Study
Non-compliant participant
|
1
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi
Baseline characteristics by cohort
| Measure |
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis
n=500 Participants
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
n=500 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg..
|
Discontinuation of Standard of Care (Control Arm)
n=499 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
Total
n=1499 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
494 Participants
n=5 Participants
|
496 Participants
n=7 Participants
|
480 Participants
n=5 Participants
|
1470 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
38.7 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
375 Participants
n=5 Participants
|
374 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
1135 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
364 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
500 Participants
n=5 Participants
|
500 Participants
n=7 Participants
|
499 Participants
n=5 Participants
|
1499 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Malawi
|
500 participants
n=5 Participants
|
500 participants
n=7 Participants
|
499 participants
n=5 Participants
|
1499 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 22-66 monthsIncidence of severe events (composite of death and WHO stage 3 and 4 illness)
Outcome measures
| Measure |
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis
n=500 Participants
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
n=500 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
n=499 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
Severe Events
|
3.3 Events per 100 participant-years
|
4.2 Events per 100 participant-years
|
4.2 Events per 100 participant-years
|
SECONDARY outcome
Timeframe: Throughout study participation, measured every six months (2-5.5 years).Number of participants who ever have a detectable viral load (\>400 copies/ml).
Outcome measures
| Measure |
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis
n=500 Participants
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
n=500 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
n=499 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
Number of Participants With at Least One Detectable HIV Viral Load
|
24 Participants
|
36 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Every 6 months for 22-66 monthsNumber of Participants with at Least One CD4 Count \<200
Outcome measures
| Measure |
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis
n=500 Participants
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
n=500 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
n=499 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
CD4 Cell Count
|
24 Participants
|
23 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 32-66 monthsIncidence of any WHO HIV stage 2, 3, or 4 illness
Outcome measures
| Measure |
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis
n=500 Participants
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
n=500 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
n=499 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
WHO HIV Stage 2, 3, 4 Illness
|
4.0 Events per 100 participant-years
|
5.7 Events per 100 participant-years
|
5.8 Events per 100 participant-years
|
SECONDARY outcome
Timeframe: 32-66 monthsIncidence of bacterial infections and malaria
Outcome measures
| Measure |
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis
n=500 Participants
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
n=500 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
n=499 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
Bacterial Infections and Malaria
|
27.8 Events per 100 participant-years
|
37.4 Events per 100 participant-years
|
36.3 Events per 100 participant-years
|
SECONDARY outcome
Timeframe: 32-66 monthsOccurrence of adverse events that are greater than or equal to Grade 3 that require discontinuation of TS or CQ prophylaxis
Outcome measures
| Measure |
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis
n=500 Participants
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
n=500 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
n=499 Participants
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
Adverse Events Greater Than or Equal to Grade 3 That Are Related to the Study Product
|
0 Events per 100 participant-years
|
0.24 Events per 100 participant-years
|
0 Events per 100 participant-years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 32-66 monthsOccurrence of bacterial or malaria infection with CQ or TS resistant organism
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 32-66 monthsClinical and parasitological response to antimalarial therapy in cases of uncomplicated malaria
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis
Serious events: 72 serious events
Other events: 488 other events
Deaths: 10 deaths
Chloroquine (CQ) Prophylaxis
Serious events: 99 serious events
Other events: 483 other events
Deaths: 6 deaths
Discontinuation of Standard of Care (Control Arm)
Serious events: 116 serious events
Other events: 488 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis
n=500 participants at risk
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
n=500 participants at risk
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
n=499 participants at risk
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
Infections and infestations
Infections
|
4.4%
22/500 • Number of events 24 • 2 to 5.5 years
|
6.4%
32/500 • Number of events 36 • 2 to 5.5 years
|
8.0%
40/499 • Number of events 48 • 2 to 5.5 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal
|
3.0%
15/500 • Number of events 21 • 2 to 5.5 years
|
5.2%
26/500 • Number of events 29 • 2 to 5.5 years
|
5.8%
29/499 • Number of events 32 • 2 to 5.5 years
|
|
Nervous system disorders
Nervous
|
1.8%
9/500 • Number of events 9 • 2 to 5.5 years
|
2.2%
11/500 • Number of events 20 • 2 to 5.5 years
|
1.4%
7/499 • Number of events 8 • 2 to 5.5 years
|
|
Injury, poisoning and procedural complications
Injuries
|
2.0%
10/500 • Number of events 10 • 2 to 5.5 years
|
1.4%
7/500 • Number of events 7 • 2 to 5.5 years
|
0.60%
3/499 • Number of events 3 • 2 to 5.5 years
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.60%
3/500 • Number of events 3 • 2 to 5.5 years
|
1.6%
8/500 • Number of events 8 • 2 to 5.5 years
|
1.6%
8/499 • Number of events 9 • 2 to 5.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
0.80%
4/500 • Number of events 5 • 2 to 5.5 years
|
1.0%
5/500 • Number of events 5 • 2 to 5.5 years
|
1.8%
9/499 • Number of events 9 • 2 to 5.5 years
|
|
Surgical and medical procedures
Surgical and medical
|
1.0%
5/500 • Number of events 5 • 2 to 5.5 years
|
1.2%
6/500 • Number of events 6 • 2 to 5.5 years
|
1.2%
6/499 • Number of events 6 • 2 to 5.5 years
|
|
General disorders
General
|
0.40%
2/500 • Number of events 2 • 2 to 5.5 years
|
0.80%
4/500 • Number of events 6 • 2 to 5.5 years
|
1.2%
6/499 • Number of events 6 • 2 to 5.5 years
|
|
Reproductive system and breast disorders
Reproductive system
|
0.60%
3/500 • Number of events 3 • 2 to 5.5 years
|
1.2%
6/500 • Number of events 7 • 2 to 5.5 years
|
0.60%
3/499 • Number of events 3 • 2 to 5.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
0.40%
2/500 • Number of events 2 • 2 to 5.5 years
|
0.60%
3/500 • Number of events 4 • 2 to 5.5 years
|
0.60%
3/499 • Number of events 5 • 2 to 5.5 years
|
|
Blood and lymphatic system disorders
Blood
|
0.80%
4/500 • Number of events 4 • 2 to 5.5 years
|
0.20%
1/500 • Number of events 2 • 2 to 5.5 years
|
0.40%
2/499 • Number of events 2 • 2 to 5.5 years
|
|
Psychiatric disorders
Psychiatric
|
0.20%
1/500 • Number of events 1 • 2 to 5.5 years
|
0.60%
3/500 • Number of events 3 • 2 to 5.5 years
|
0.40%
2/499 • Number of events 2 • 2 to 5.5 years
|
|
Eye disorders
Eye
|
0.20%
1/500 • Number of events 1 • 2 to 5.5 years
|
0.20%
1/500 • Number of events 1 • 2 to 5.5 years
|
0.40%
2/499 • Number of events 2 • 2 to 5.5 years
|
|
Vascular disorders
Vascular
|
0.00%
0/500 • 2 to 5.5 years
|
0.00%
0/500 • 2 to 5.5 years
|
0.80%
4/499 • Number of events 4 • 2 to 5.5 years
|
|
Metabolism and nutrition disorders
Metabolism
|
0.00%
0/500 • 2 to 5.5 years
|
0.40%
2/500 • Number of events 2 • 2 to 5.5 years
|
0.20%
1/499 • Number of events 1 • 2 to 5.5 years
|
|
Cardiac disorders
Cardiac
|
0.20%
1/500 • Number of events 1 • 2 to 5.5 years
|
0.20%
1/500 • Number of events 1 • 2 to 5.5 years
|
0.00%
0/499 • 2 to 5.5 years
|
|
Endocrine disorders
Endocrine
|
0.20%
1/500 • Number of events 1 • 2 to 5.5 years
|
0.00%
0/500 • 2 to 5.5 years
|
0.20%
1/499 • Number of events 1 • 2 to 5.5 years
|
|
Hepatobiliary disorders
Hepatobiliary
|
0.40%
2/500 • Number of events 2 • 2 to 5.5 years
|
0.00%
0/500 • 2 to 5.5 years
|
0.00%
0/499 • 2 to 5.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.20%
1/500 • Number of events 1 • 2 to 5.5 years
|
0.20%
1/500 • Number of events 1 • 2 to 5.5 years
|
0.00%
0/499 • 2 to 5.5 years
|
|
Renal and urinary disorders
Renal
|
0.40%
2/500 • Number of events 2 • 2 to 5.5 years
|
0.00%
0/500 • 2 to 5.5 years
|
0.00%
0/499 • 2 to 5.5 years
|
Other adverse events
| Measure |
Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis
n=500 participants at risk
Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
|
Chloroquine (CQ) Prophylaxis
n=500 participants at risk
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
|
Discontinuation of Standard of Care (Control Arm)
n=499 participants at risk
Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
|
|---|---|---|---|
|
Infections and infestations
Infections
|
82.8%
414/500 • 2 to 5.5 years
|
85.6%
428/500 • 2 to 5.5 years
|
88.8%
443/499 • 2 to 5.5 years
|
|
General disorders
General
|
60.8%
304/500 • 2 to 5.5 years
|
53.4%
267/500 • 2 to 5.5 years
|
62.5%
312/499 • 2 to 5.5 years
|
|
Investigations
Investigations
|
59.6%
298/500 • 2 to 5.5 years
|
61.4%
307/500 • 2 to 5.5 years
|
55.7%
278/499 • 2 to 5.5 years
|
|
Gastrointestinal disorders
Gastrointestinal
|
49.6%
248/500 • 2 to 5.5 years
|
48.6%
243/500 • 2 to 5.5 years
|
58.3%
291/499 • 2 to 5.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
51.2%
256/500 • 2 to 5.5 years
|
44.6%
223/500 • 2 to 5.5 years
|
52.9%
264/499 • 2 to 5.5 years
|
|
Blood and lymphatic system disorders
Blood
|
48.0%
240/500 • 2 to 5.5 years
|
44.4%
222/500 • 2 to 5.5 years
|
41.1%
205/499 • 2 to 5.5 years
|
|
Nervous system disorders
Nervous
|
43.4%
217/500 • 2 to 5.5 years
|
41.8%
209/500 • 2 to 5.5 years
|
44.9%
224/499 • 2 to 5.5 years
|
|
Skin and subcutaneous tissue disorders
Skin
|
28.0%
140/500 • 2 to 5.5 years
|
26.6%
133/500 • 2 to 5.5 years
|
27.7%
138/499 • 2 to 5.5 years
|
|
Eye disorders
Eye
|
24.4%
122/500 • 2 to 5.5 years
|
26.0%
130/500 • 2 to 5.5 years
|
25.3%
126/499 • 2 to 5.5 years
|
|
Reproductive system and breast disorders
Reproductive system
|
17.0%
85/500 • 2 to 5.5 years
|
18.8%
94/500 • 2 to 5.5 years
|
18.6%
93/499 • 2 to 5.5 years
|
|
Injury, poisoning and procedural complications
Injuries
|
17.0%
85/500 • 2 to 5.5 years
|
16.4%
82/500 • 2 to 5.5 years
|
15.8%
79/499 • 2 to 5.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
11.8%
59/500 • 2 to 5.5 years
|
13.0%
65/500 • 2 to 5.5 years
|
11.8%
59/499 • 2 to 5.5 years
|
|
Vascular disorders
Vascular
|
3.4%
17/500 • 2 to 5.5 years
|
5.8%
29/500 • 2 to 5.5 years
|
6.2%
31/499 • 2 to 5.5 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal
|
3.4%
17/500 • 2 to 5.5 years
|
5.4%
27/500 • 2 to 5.5 years
|
5.8%
29/499 • 2 to 5.5 years
|
|
Metabolism and nutrition disorders
Metabolism
|
4.6%
23/500 • 2 to 5.5 years
|
5.2%
26/500 • 2 to 5.5 years
|
4.4%
22/499 • 2 to 5.5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth
|
3.6%
18/500 • 2 to 5.5 years
|
4.8%
24/500 • 2 to 5.5 years
|
3.6%
18/499 • 2 to 5.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
3.0%
15/500 • 2 to 5.5 years
|
4.6%
23/500 • 2 to 5.5 years
|
3.2%
16/499 • 2 to 5.5 years
|
|
Cardiac disorders
Cardiac
|
2.6%
13/500 • 2 to 5.5 years
|
3.0%
15/500 • 2 to 5.5 years
|
3.8%
19/499 • 2 to 5.5 years
|
|
Renal and urinary disorders
Renal
|
2.2%
11/500 • 2 to 5.5 years
|
3.4%
17/500 • 2 to 5.5 years
|
3.8%
19/499 • 2 to 5.5 years
|
|
Psychiatric disorders
Psychiatric
|
1.4%
7/500 • 2 to 5.5 years
|
2.0%
10/500 • 2 to 5.5 years
|
1.0%
5/499 • 2 to 5.5 years
|
|
Surgical and medical procedures
Surgical and medical
|
1.2%
6/500 • 2 to 5.5 years
|
1.2%
6/500 • 2 to 5.5 years
|
1.4%
7/499 • 2 to 5.5 years
|
|
Hepatobiliary disorders
Hepatobiliary
|
0.40%
2/500 • 2 to 5.5 years
|
0.40%
2/500 • 2 to 5.5 years
|
0.60%
3/499 • 2 to 5.5 years
|
|
Endocrine disorders
Endocrine
|
0.20%
1/500 • 2 to 5.5 years
|
0.20%
1/500 • 2 to 5.5 years
|
0.40%
2/499 • 2 to 5.5 years
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic
|
0.00%
0/500 • 2 to 5.5 years
|
0.20%
1/500 • 2 to 5.5 years
|
0.20%
1/499 • 2 to 5.5 years
|
Additional Information
Miriam K. Laufer, M.D., M.P.H.
University of Maryland School of Medicine
Phone: 410-706-5333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place