Trial Outcomes & Findings for HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children (NCT NCT00978068)
NCT ID: NCT00978068
Last Updated: 2018-12-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
176 participants
Primary outcome timeframe
Time from randomization to at least 24 months of follow up or until end of the study
Results posted on
2018-12-28
Participant Flow
Children were recruited from September 2009 through July 2011.
A total of 404 children were screened for eligibility; 228 were found not to be eligible. The main reasons for ineligibility were: 136 Were not eligible for ART 34 Were on ART with detectable viral load 32 Were HIV- 8 Had not received ART but had prior exposure to nevirapine
Participant milestones
| Measure |
LPV/r + 2 NRTIs
LPV/r + 2 NRTIs: Group 1
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
NVP or EFV + 2 NRTIs
NVP or EFV + 2 NRTIs: Group 2
Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
89
|
|
Overall Study
Initiated Study Drugs
|
84
|
86
|
|
Overall Study
COMPLETED
|
83
|
80
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
LPV/r + 2 NRTIs
LPV/r + 2 NRTIs: Group 1
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
NVP or EFV + 2 NRTIs
NVP or EFV + 2 NRTIs: Group 2
Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
Overall Study
Were Awaiting Initiation of ART
|
2
|
2
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Unable to Comply with Study
|
0
|
2
|
Baseline Characteristics
HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
Baseline characteristics by cohort
| Measure |
LPV/r + 2 NRTIs
n=84 Participants
LPV/r + 2 NRTIs: Group 1
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
NVP or EFV + 2 NRTIs
n=86 Participants
NVP or EFV + 2 NRTIs: Group 2
Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.9 years
n=5 Participants
|
3.1 years
n=7 Participants
|
3.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Previous ART to Enrollment
No Previous ART
|
57 participants
n=5 Participants
|
58 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Previous ART to Enrollment
Previous ART
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
WHO Clinical HIV stage
Stage I (Asymptomatic)
|
60 participants
n=5 Participants
|
66 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
WHO Clinical HIV stage
Stage II (mod. unexplained weight loss)
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
WHO Clinical HIV stage
Stage III (unexplained severe weight loss)
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
WHO Clinical HIV stage
Stage IV (HIV wasting syndrome)
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
CD4 Percentage
No Previous ART
|
14 % of white cells that are CD4 cells
n=5 Participants
|
16 % of white cells that are CD4 cells
n=7 Participants
|
16 % of white cells that are CD4 cells
n=5 Participants
|
|
CD4 Percentage
Previous ART
|
31 % of white cells that are CD4 cells
n=5 Participants
|
30 % of white cells that are CD4 cells
n=7 Participants
|
30 % of white cells that are CD4 cells
n=5 Participants
|
|
Viral Load
No Previous ART
|
5.4 log10copies/mL
n=5 Participants
|
5.5 log10copies/mL
n=7 Participants
|
5.5 log10copies/mL
n=5 Participants
|
|
Viral Load
Previous ART
|
NA log10copies/mL
n=5 Participants
|
NA log10copies/mL
n=7 Participants
|
NA log10copies/mL
n=5 Participants
|
|
Hemoglobin
|
10.4 g/dL
STANDARD_DEVIATION 1.3 • n=5 Participants
|
10.6 g/dL
STANDARD_DEVIATION 1.5 • n=7 Participants
|
10.5 g/dL
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Result of Baseline Blood Smear for Asexual Parasites
Positive
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Result of Baseline Blood Smear for Asexual Parasites
Negative
|
74 participants
n=5 Participants
|
75 participants
n=7 Participants
|
149 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to at least 24 months of follow up or until end of the studyOutcome measures
| Measure |
Group 1: LPV/r + 2 NRTIs
n=84 Participants
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs
n=86 Participants
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk.
|
1.32 Episodes/ Person-Yr at Risk
|
2.25 Episodes/ Person-Yr at Risk
|
SECONDARY outcome
Timeframe: 28 days after antimalarial therapyThe rates of adverse events, defined as severity grade 2 or higher that are possibly, probably or definitely related to study drugs over the course of the 28-day period after antimalarial therapy with artemether-lumefantrine (AL).
Outcome measures
| Measure |
Group 1: LPV/r + 2 NRTIs
n=84 Participants
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs
n=86 Participants
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
Percentage of Uncomplicated Malaria Episodes With Accompanying Adverse Events That Occurred in the 28 Days Following Antimalarial Therapy
|
71.0 % uncomplicated malaria episodes w/ AEs
|
79.3 % uncomplicated malaria episodes w/ AEs
|
SECONDARY outcome
Timeframe: Time from randomization to at least 24 months of follow up or until end of the studyOutcome measures
| Measure |
Group 1: LPV/r + 2 NRTIs
n=84 Participants
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs
n=86 Participants
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
Incidence-density of Malaria Defined as the Number of Incident Episodes of Complicated Malaria Per Time at Risk.
|
0.024 Episodes/ Person-Yr at Risk
|
0.026 Episodes/ Person-Yr at Risk
|
SECONDARY outcome
Timeframe: Enrollment to 6 months follow upPopulation: Among patients who were followed for 6 months, malaria did not develop in 34 patients in the NNRTI group and 44 in the lopinavir-ritonavir group; data on 10 patients in the NNRTI group and 7 in the lopinavir-ritonavir group were censored before the 6-month follow-up assessment.
To assess the effect of ART independently of potential interactions with antimalarial therapy after treatment for malaria, we compared the two groups with respect to the time to the first episode of malaria. Cumulative risk was estimated using the Kaplan-Meier product-limit formula.
Outcome measures
| Measure |
Group 1: LPV/r + 2 NRTIs
n=84 Participants
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs
n=86 Participants
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
Estimates of the 6-month Risk of a First Episode of Malaria
|
40.7 Cumulative Risk Percentage
Interval 30.9 to 52.2
|
52.5 Cumulative Risk Percentage
Interval 42.0 to 63.9
|
SECONDARY outcome
Timeframe: 28 days after antimalarial therapyPopulation: The risk of recurrence was assessed among patients who had had uncomplicated malaria that had been treated with artemether-lumefantrine.
To assess the effect of potential interactions between ART and artemether-lumefantrine, the risks of recurrent parasitemia at 28 days were compared between the two groups.
Outcome measures
| Measure |
Group 1: LPV/r + 2 NRTIs
n=84 Participants
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs
n=86 Participants
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
28-day Risk of Recurrent Parasitemia
|
14.0 Cummulative Risk Percentage
Interval 8.7 to 22.2
|
40.8 Cummulative Risk Percentage
Interval 33.9 to 48.6
|
SECONDARY outcome
Timeframe: 28 days after antimalarial therapyPopulation: The risk of recurrence was assessed among patients who had had uncomplicated malaria that had been treated with artemether-lumefantrine.
To assess the effect of potential interactions between ART and artemether-lumefantrine, the risks of recurrent malaria at 63 days were compared between the two groups.
Outcome measures
| Measure |
Group 1: LPV/r + 2 NRTIs
n=84 Participants
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs
n=86 Participants
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
63-day Risk of Recurrent Malaria
|
28.1 Cumulative Risk Percentage
Interval 20.2 to 38.3
|
54.2 Cumulative Risk Percentage
Interval 46.4 to 62.2
|
Adverse Events
Group 1
Serious events: 11 serious events
Other events: 41 other events
Deaths: 0 deaths
Group 2
Serious events: 9 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=84 participants at risk
LPV/r + 2 NRTIs
LPV/r + 2 NRTIs: Group 1
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
Group 2
n=86 participants at risk
NVP or EFV + 2 NRTIs
NVP or EFV + 2 NRTIs: Group 2
Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
2/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
3.5%
3/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
0.00%
0/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Blood and lymphatic system disorders
Dehydration
|
0.00%
0/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
1/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea/respiratory distress
|
4.8%
4/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
3.5%
3/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Hepatobiliary disorders
Elevated ALT
|
2.4%
2/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
2.3%
2/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Endocrine disorders
Elevated Temperature/Fever
|
2.4%
2/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.2%
1/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
0.00%
0/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Blood and lymphatic system disorders
Neutropenia/Absolute neutrophil count
|
8.3%
7/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
10.5%
9/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Nervous system disorders
Seizure
|
2.4%
2/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Renal and urinary disorders
Hypoglycemia
|
0.00%
0/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson Syndrome
|
0.00%
0/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Blood and lymphatic system disorders
Thrombocytopenia Platelets, decreased
|
3.6%
3/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Metabolism and nutrition disorders
Unintentional weight loss
|
0.00%
0/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
Other adverse events
| Measure |
Group 1
n=84 participants at risk
LPV/r + 2 NRTIs
LPV/r + 2 NRTIs: Group 1
Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)
The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
|
Group 2
n=86 participants at risk
NVP or EFV + 2 NRTIs
NVP or EFV + 2 NRTIs: Group 2
Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI
NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
2/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
4.7%
4/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Endocrine disorders
Chills
|
2.4%
2/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
0.00%
0/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Hepatobiliary disorders
Elevated ALT
|
2.4%
2/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
3.5%
3/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Hepatobiliary disorders
Elevated AST
|
1.2%
1/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Endocrine disorders
Elevated Temperature
|
22.6%
19/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
27.9%
24/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.6%
24/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
24.4%
21/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Skin and subcutaneous tissue disorders
Pallor
|
0.00%
0/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Skin and subcutaneous tissue disorders
Rash (non-infectious)
|
0.00%
0/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Metabolism and nutrition disorders
Severe Malnutrition
|
0.00%
0/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
1.2%
1/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Blood and lymphatic system disorders
Thrombocytopenia Platelets, decreased
|
10.7%
9/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
7.0%
6/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Metabolism and nutrition disorders
Unintentional weight loss
|
1.2%
1/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
0.00%
0/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
|
Blood and lymphatic system disorders
WBC, decreased
|
1.2%
1/84 • Time from randomization to at least 24 months of follow up or until end of the study
|
2.3%
2/86 • Time from randomization to at least 24 months of follow up or until end of the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place