Trial Outcomes & Findings for Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ) (NCT NCT00441285)
NCT ID: NCT00441285
Last Updated: 2015-06-11
Results Overview
\- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
156 participants
Primary outcome timeframe
0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1
Results posted on
2015-06-11
Participant Flow
This protocol (2 groups, n=180) was modified by the DSMB to add a pharmacokinetics / safety substudy (two groups, n=32). After the substudy results were available, we were approved to proceed with a modified study design (3 groups, n=240). This second study was terminated after enroling patient 124 because of early efficacy (total n= 132+24, 156)
Participant milestones
| Measure |
PK Substudy ABZ+PZQ
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
PK Substudy ABZ+Placebo
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
Phase III Trial - ABZ+PZQ
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Phase III Trial - Increased ABZ
* Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d, for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Phase III Trial - Standard ABZ
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)
* Placebo of Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
41
|
40
|
43
|
|
Overall Study
COMPLETED
|
16
|
16
|
41
|
40
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)
Baseline characteristics by cohort
| Measure |
Albendazole + Praziquantel
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
Phase III Trial ABZ+PZQ
n=41 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* A placebo of ABZ was added to complete to the doses in the Increased ABZ arm
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 10 days.
|
Phase III Trial Increased ABZ
n=40 Participants
* Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 10 days.
|
Phase III Trial Standard ABZ
n=43 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* A placebo of ABZ was added to complete the doses to the dosage in the Increased ABZ arm
* Praziquantel placebo was given in two daily doses, morning and evening,for 10 days.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
146 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 11 • n=7 Participants
|
34 years
STANDARD_DEVIATION 14 • n=5 Participants
|
34 years
STANDARD_DEVIATION 12 • n=4 Participants
|
35 years
STANDARD_DEVIATION 13 • n=21 Participants
|
28 years
STANDARD_DEVIATION 10.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
59 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
97 Participants
n=10 Participants
|
|
Region of Enrollment
Peru
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
41 participants
n=5 Participants
|
40 participants
n=4 Participants
|
43 participants
n=21 Participants
|
156 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1\- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).
Outcome measures
| Measure |
Albendazole + Praziquantel
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
Phase III Trial - Standard ABZ
Main Trial, Arm receiving standard ABZ doses, no PZQ
|
|---|---|---|---|
|
PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1
|
1412.2 ng*h/mL
95% Confidence Interval 58124.7 • Interval 1115.5 to 1709.0
|
1111 ng*h/mL
95% Confidence Interval 32257.1 • Interval 931.1 to 1290.8
|
—
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on Treatment days 10-11\- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).
Outcome measures
| Measure |
Albendazole + Praziquantel
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
Phase III Trial - Standard ABZ
Main Trial, Arm receiving standard ABZ doses, no PZQ
|
|---|---|---|---|
|
PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11
|
4925.3 ng*h/ml
Interval 3548.6 to 6302.0
|
2969.6 ng*h/ml
Interval 2543.8 to 3395.4
|
—
|
PRIMARY outcome
Timeframe: Treatment day 1 and Treatment days 10-11Highest serum level of Albendazole measured from all level assessments in the curve.
Outcome measures
| Measure |
Albendazole + Praziquantel
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
Phase III Trial - Standard ABZ
Main Trial, Arm receiving standard ABZ doses, no PZQ
|
|---|---|---|---|
|
PK Substudy - Maximum Concentration of Albendazole
|
1293.9 ng/mL
Standard Deviation 3471.6
|
2232.8 ng/mL
Standard Deviation 6500.7
|
—
|
PRIMARY outcome
Timeframe: Day 180Population: Some patients did not reach the analysis time point.
Proportion of patients whose 6 month MR does not show viable parasites anymore
Outcome measures
| Measure |
Albendazole + Praziquantel
n=39 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
n=38 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
Phase III Trial - Standard ABZ
n=42 Participants
Main Trial, Arm receiving standard ABZ doses, no PZQ
|
|---|---|---|---|
|
Phase III Trial - Proportion of Patients Without Remaining Live Cysts
|
25 participants
|
19 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose in treatment day 1Population: Carbamazepine and Phenytoin were not assigned by the study.
\- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin
Outcome measures
| Measure |
Albendazole + Praziquantel
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
Phase III Trial - Standard ABZ
Main Trial, Arm receiving standard ABZ doses, no PZQ
|
|---|---|---|---|
|
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1
Carbamazepine (n=8)
|
548.3 ng*h / mL
Standard Deviation 320.9
|
—
|
—
|
|
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1
Phenytoin (n=8)
|
923.7 ng*h / mL
Standard Deviation 424.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11\- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin
Outcome measures
| Measure |
Albendazole + Praziquantel
n=8 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
n=8 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
Phase III Trial - Standard ABZ
Main Trial, Arm receiving standard ABZ doses, no PZQ
|
|---|---|---|---|
|
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11
|
240.2 ng*h/ml
Interval 151.7 to 328.7
|
550.1 ng*h/ml
Interval 83.3 to 1183.4
|
—
|
SECONDARY outcome
Timeframe: 90 days post tx\- Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.
Outcome measures
| Measure |
Albendazole + Praziquantel
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
n=16 Participants
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
Phase III Trial - Standard ABZ
Main Trial, Arm receiving standard ABZ doses, no PZQ
|
|---|---|---|---|
|
PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy
|
0 Events
|
0 Events
|
—
|
SECONDARY outcome
Timeframe: Day 180Population: Final population numbers for this analysis not yet defined
Proportion of Viable Brain Parasites which Are not Alive Anymore at 6 Months MRI
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 - 540Population: Final population numbers for this analysis not yet defined
Seizure frequency by treatment group
Outcome measures
Outcome data not reported
Adverse Events
Albendazole + Praziquantel
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Albendazole + Placebo
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Albendazole + Praziquantel
n=16 participants at risk
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
n=16 participants at risk
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
|---|---|---|
|
Nervous system disorders
Prolonged hospitalization
|
12.5%
2/16 • Number of events 2 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
12.5%
2/16 • Number of events 2 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
Other adverse events
| Measure |
Albendazole + Praziquantel
n=16 participants at risk
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days.
|
Albendazole + Placebo
n=16 participants at risk
* Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
* Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days.
|
|---|---|---|
|
Nervous system disorders
Headache
|
25.0%
4/16 • Number of events 6 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
31.2%
5/16 • Number of events 9 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
0.00%
0/16 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Number of events 2 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
12.5%
2/16 • Number of events 2 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Skin and subcutaneous tissue disorders
Acne
|
12.5%
2/16 • Number of events 2 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
0.00%
0/16 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Gastrointestinal disorders
Decreased indirect bilirubin
|
6.2%
1/16 • Number of events 1 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
0.00%
0/16 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Blood and lymphatic system disorders
Decreased neutrophilos
|
6.2%
1/16 • Number of events 1 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
0.00%
0/16 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Blood and lymphatic system disorders
Decreased Red blood cells
|
6.2%
1/16 • Number of events 1 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
0.00%
0/16 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Blood and lymphatic system disorders
Decreased White blood cells
|
12.5%
2/16 • Number of events 2 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
6.2%
1/16 • Number of events 1 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
6.2%
1/16 • Number of events 1 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
12.5%
2/16 • Number of events 2 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/16 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
18.8%
3/16 • Number of events 4 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Gastrointestinal disorders
Increased ALT
|
50.0%
8/16 • Number of events 9 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
62.5%
10/16 • Number of events 17 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Gastrointestinal disorders
Increased AST
|
18.8%
3/16 • Number of events 3 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
43.8%
7/16 • Number of events 9 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
12.5%
2/16 • Number of events 2 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Nervous system disorders
Paresis
|
0.00%
0/16 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
6.2%
1/16 • Number of events 1 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
|
Nervous system disorders
Paresthesia
|
6.2%
1/16 • Number of events 2 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
6.2%
1/16 • Number of events 1 • Number of Serious Adverse Events along the entire follow up (Days 1 - 540)
Adverse events by treatment arm in Phase III arms are not yet available because of the blinded nature of the trial
|
Additional Information
Hector H. Garcia, MD, PhD
Universidad Peruana Cayetano Heredia
Phone: +511 3287360
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place