Trial Outcomes & Findings for Efficacy and Safety of IVM/ALB Co-administration (NCT NCT03527732)
NCT ID: NCT03527732
Last Updated: 2024-03-20
Results Overview
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1673 participants
Primary outcome timeframe
14-21 days after treatment
Results posted on
2024-03-20
Participant Flow
Participant milestones
| Measure |
Albendazole in Côte d'Ivoire
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole and Ivermectin in Côte d'Ivoire
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole in Laos
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole and Ivermectin in Laos
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole in Pemba Island
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Albendazole and Ivermectin in Pemba Island
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
256
|
255
|
274
|
275
|
305
|
308
|
|
Overall Study
COMPLETED
|
235
|
232
|
194
|
213
|
293
|
288
|
|
Overall Study
NOT COMPLETED
|
21
|
23
|
80
|
62
|
12
|
20
|
Reasons for withdrawal
| Measure |
Albendazole in Côte d'Ivoire
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole and Ivermectin in Côte d'Ivoire
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole in Laos
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole and Ivermectin in Laos
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole in Pemba Island
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Albendazole and Ivermectin in Pemba Island
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
23
|
80
|
62
|
12
|
20
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Albendazole in Côte d'Ivoire
n=256 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole and Ivermectin in Côte d'Ivoire
n=255 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole in Laos
n=274 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole and Ivermectin in Laos
n=275 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole in Pemba Island
n=305 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Albendazole and Ivermectin in Pemba Island
n=308 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Total
n=1673 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
16.5 years
STANDARD_DEVIATION 14.1 • n=256 Participants
|
16.0 years
STANDARD_DEVIATION 13.4 • n=255 Participants
|
27.7 years
STANDARD_DEVIATION 17.3 • n=274 Participants
|
25.9 years
STANDARD_DEVIATION 17.4 • n=275 Participants
|
14.0 years
STANDARD_DEVIATION 10.5 • n=305 Participants
|
13.9 years
STANDARD_DEVIATION 9.6 • n=308 Participants
|
18.9 years
STANDARD_DEVIATION 15.0 • n=1673 Participants
|
|
Age, Customized
School-aged (6-12 years)
|
171 participants
n=256 Participants
|
168 participants
n=255 Participants
|
92 participants
n=274 Participants
|
113 participants
n=275 Participants
|
191 participants
n=305 Participants
|
184 participants
n=308 Participants
|
919 participants
n=1673 Participants
|
|
Age, Customized
Youth or young people (13-24 years)
|
30 participants
n=256 Participants
|
36 participants
n=255 Participants
|
37 participants
n=274 Participants
|
30 participants
n=275 Participants
|
81 participants
n=305 Participants
|
90 participants
n=308 Participants
|
304 participants
n=1673 Participants
|
|
Age, Customized
Adults (25-60 years)
|
55 participants
n=256 Participants
|
51 participants
n=255 Participants
|
145 participants
n=274 Participants
|
132 participants
n=275 Participants
|
33 participants
n=305 Participants
|
34 participants
n=308 Participants
|
450 participants
n=1673 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=256 Participants
|
129 Participants
n=255 Participants
|
144 Participants
n=274 Participants
|
147 Participants
n=275 Participants
|
171 Participants
n=305 Participants
|
169 Participants
n=308 Participants
|
880 Participants
n=1673 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=256 Participants
|
126 Participants
n=255 Participants
|
130 Participants
n=274 Participants
|
128 Participants
n=275 Participants
|
134 Participants
n=305 Participants
|
139 Participants
n=308 Participants
|
793 Participants
n=1673 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
37.5 kg
STANDARD_DEVIATION 20.1 • n=256 Participants
|
37.2 kg
STANDARD_DEVIATION 19.7 • n=255 Participants
|
41.1 kg
STANDARD_DEVIATION 14.5 • n=274 Participants
|
39.7 kg
STANDARD_DEVIATION 15.7 • n=275 Participants
|
34.2 kg
STANDARD_DEVIATION 15.5 • n=305 Participants
|
34.0 kg
STANDARD_DEVIATION 14.8 • n=308 Participants
|
37.2 kg
STANDARD_DEVIATION 16.9 • n=1673 Participants
|
|
Height
|
136.7 cm
STANDARD_DEVIATION 20.3 • n=256 Participants • One individual value from the Albendazole group in Laos omitted due to irrational value (479 cm).
|
135.8 cm
STANDARD_DEVIATION 19.4 • n=255 Participants • One individual value from the Albendazole group in Laos omitted due to irrational value (479 cm).
|
144.3 cm
STANDARD_DEVIATION 16.6 • n=273 Participants • One individual value from the Albendazole group in Laos omitted due to irrational value (479 cm).
|
142.3 cm
STANDARD_DEVIATION 16.7 • n=275 Participants • One individual value from the Albendazole group in Laos omitted due to irrational value (479 cm).
|
137.3 cm
STANDARD_DEVIATION 18.6 • n=305 Participants • One individual value from the Albendazole group in Laos omitted due to irrational value (479 cm).
|
137.7 cm
STANDARD_DEVIATION 18.9 • n=308 Participants • One individual value from the Albendazole group in Laos omitted due to irrational value (479 cm).
|
139.0 cm
STANDARD_DEVIATION 18.7 • n=1672 Participants • One individual value from the Albendazole group in Laos omitted due to irrational value (479 cm).
|
|
T. trichiura geometric mean egg counts
|
481 Eggs per gram of stool
n=256 Participants
|
470 Eggs per gram of stool
n=255 Participants
|
366 Eggs per gram of stool
n=274 Participants
|
349 Eggs per gram of stool
n=275 Participants
|
467 Eggs per gram of stool
n=305 Participants
|
461 Eggs per gram of stool
n=308 Participants
|
429 Eggs per gram of stool
n=1673 Participants
|
|
T. trichiura infection intensity
Light (1-999 EPG)
|
190 Participants
n=256 Participants
|
192 Participants
n=255 Participants
|
232 Participants
n=274 Participants
|
232 Participants
n=275 Participants
|
231 Participants
n=305 Participants
|
234 Participants
n=308 Participants
|
1311 Participants
n=1673 Participants
|
|
T. trichiura infection intensity
Moderate (1000-9999 EPG)
|
64 Participants
n=256 Participants
|
60 Participants
n=255 Participants
|
42 Participants
n=274 Participants
|
42 Participants
n=275 Participants
|
74 Participants
n=305 Participants
|
71 Participants
n=308 Participants
|
353 Participants
n=1673 Participants
|
|
T. trichiura infection intensity
heavy (≥10 000 EPG)
|
2 Participants
n=256 Participants
|
3 Participants
n=255 Participants
|
0 Participants
n=274 Participants
|
1 Participants
n=275 Participants
|
0 Participants
n=305 Participants
|
3 Participants
n=308 Participants
|
9 Participants
n=1673 Participants
|
|
A. lumbricoides geometric mean egg counts
|
5499 Eggs per gram of stool
n=91 Participants • Only A. lumbricoides co-infected participants considered.
|
4130 Eggs per gram of stool
n=91 Participants • Only A. lumbricoides co-infected participants considered.
|
3991 Eggs per gram of stool
n=112 Participants • Only A. lumbricoides co-infected participants considered.
|
3635 Eggs per gram of stool
n=96 Participants • Only A. lumbricoides co-infected participants considered.
|
4515 Eggs per gram of stool
n=74 Participants • Only A. lumbricoides co-infected participants considered.
|
2979 Eggs per gram of stool
n=90 Participants • Only A. lumbricoides co-infected participants considered.
|
4036 Eggs per gram of stool
n=554 Participants • Only A. lumbricoides co-infected participants considered.
|
|
A. lumbricoides infection intensity
Light (1-4999 EPG)
|
38 Participants
n=91 Participants • Only A. lumbricoides co-infected participants considered.
|
42 Participants
n=91 Participants • Only A. lumbricoides co-infected participants considered.
|
58 Participants
n=112 Participants • Only A. lumbricoides co-infected participants considered.
|
48 Participants
n=96 Participants • Only A. lumbricoides co-infected participants considered.
|
35 Participants
n=74 Participants • Only A. lumbricoides co-infected participants considered.
|
52 Participants
n=90 Participants • Only A. lumbricoides co-infected participants considered.
|
273 Participants
n=554 Participants • Only A. lumbricoides co-infected participants considered.
|
|
A. lumbricoides infection intensity
Moderate (5000-49 999 EPG)
|
40 Participants
n=91 Participants • Only A. lumbricoides co-infected participants considered.
|
39 Participants
n=91 Participants • Only A. lumbricoides co-infected participants considered.
|
47 Participants
n=112 Participants • Only A. lumbricoides co-infected participants considered.
|
44 Participants
n=96 Participants • Only A. lumbricoides co-infected participants considered.
|
38 Participants
n=74 Participants • Only A. lumbricoides co-infected participants considered.
|
37 Participants
n=90 Participants • Only A. lumbricoides co-infected participants considered.
|
245 Participants
n=554 Participants • Only A. lumbricoides co-infected participants considered.
|
|
A. lumbricoides infection intensity
Heavy (≥50 000 EPG)
|
13 Participants
n=91 Participants • Only A. lumbricoides co-infected participants considered.
|
10 Participants
n=91 Participants • Only A. lumbricoides co-infected participants considered.
|
7 Participants
n=112 Participants • Only A. lumbricoides co-infected participants considered.
|
4 Participants
n=96 Participants • Only A. lumbricoides co-infected participants considered.
|
1 Participants
n=74 Participants • Only A. lumbricoides co-infected participants considered.
|
1 Participants
n=90 Participants • Only A. lumbricoides co-infected participants considered.
|
36 Participants
n=554 Participants • Only A. lumbricoides co-infected participants considered.
|
|
Hookworm geometric mean egg counts
|
82 Eggs per gram of stool
n=31 Participants • Only hookworm co-infected participants considered.
|
91 Eggs per gram of stool
n=18 Participants • Only hookworm co-infected participants considered.
|
805 Eggs per gram of stool
n=250 Participants • Only hookworm co-infected participants considered.
|
840 Eggs per gram of stool
n=253 Participants • Only hookworm co-infected participants considered.
|
100 Eggs per gram of stool
n=53 Participants • Only hookworm co-infected participants considered.
|
80 Eggs per gram of stool
n=42 Participants • Only hookworm co-infected participants considered.
|
501 Eggs per gram of stool
n=647 Participants • Only hookworm co-infected participants considered.
|
|
Hookworm infection intensity
Light (1-1999 EPG)
|
31 Participants
n=31 Participants • Only hookworm co-infected participants considered.
|
16 Participants
n=18 Participants • Only hookworm co-infected participants considered.
|
182 Participants
n=250 Participants • Only hookworm co-infected participants considered.
|
184 Participants
n=253 Participants • Only hookworm co-infected participants considered.
|
53 Participants
n=53 Participants • Only hookworm co-infected participants considered.
|
42 Participants
n=42 Participants • Only hookworm co-infected participants considered.
|
508 Participants
n=647 Participants • Only hookworm co-infected participants considered.
|
|
Hookworm infection intensity
Moderate (2000-3999 EPG)
|
0 Participants
n=31 Participants • Only hookworm co-infected participants considered.
|
0 Participants
n=18 Participants • Only hookworm co-infected participants considered.
|
37 Participants
n=250 Participants • Only hookworm co-infected participants considered.
|
43 Participants
n=253 Participants • Only hookworm co-infected participants considered.
|
0 Participants
n=53 Participants • Only hookworm co-infected participants considered.
|
0 Participants
n=42 Participants • Only hookworm co-infected participants considered.
|
80 Participants
n=647 Participants • Only hookworm co-infected participants considered.
|
|
Hookworm infection intensity
Heavy (≥4000 EPG)
|
0 Participants
n=31 Participants • Only hookworm co-infected participants considered.
|
2 Participants
n=18 Participants • Only hookworm co-infected participants considered.
|
31 Participants
n=250 Participants • Only hookworm co-infected participants considered.
|
26 Participants
n=253 Participants • Only hookworm co-infected participants considered.
|
0 Participants
n=53 Participants • Only hookworm co-infected participants considered.
|
0 Participants
n=42 Participants • Only hookworm co-infected participants considered.
|
59 Participants
n=647 Participants • Only hookworm co-infected participants considered.
|
|
S. stercoralis infection
|
0 Participants
Baermann technique to detect S. stercoralis infection was applied only to stool samples collected in Laos; two participants (one in each group) had no S. stercoralis result.
|
0 Participants
Baermann technique to detect S. stercoralis infection was applied only to stool samples collected in Laos; two participants (one in each group) had no S. stercoralis result.
|
29 Participants
n=273 Participants • Baermann technique to detect S. stercoralis infection was applied only to stool samples collected in Laos; two participants (one in each group) had no S. stercoralis result.
|
30 Participants
n=274 Participants • Baermann technique to detect S. stercoralis infection was applied only to stool samples collected in Laos; two participants (one in each group) had no S. stercoralis result.
|
—
|
—
|
59 Participants
n=547 Participants • Baermann technique to detect S. stercoralis infection was applied only to stool samples collected in Laos; two participants (one in each group) had no S. stercoralis result.
|
PRIMARY outcome
Timeframe: 14-21 days after treatmentPopulation: An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis.
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Outcome measures
| Measure |
Albendazole in Côte d'Ivoire
n=235 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole and Ivermectin in Côte d'Ivoire
n=232 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole in Laos
n=194 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole and Ivermectin in Laos
n=213 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole in Pemba Island
n=293 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Albendazole and Ivermectin in Pemba Island
n=288 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
|---|---|---|---|---|---|---|
|
Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured)
Cured
|
24 Participants
|
32 Participants
|
16 Participants
|
140 Participants
|
18 Participants
|
140 Participants
|
|
Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured)
Not cured
|
211 Participants
|
200 Participants
|
178 Participants
|
73 Participants
|
275 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 months after treatmentPopulation: An analysis set of all randomized participants who provided any follow-up data at 6 or 12 months post treatment was used to perform an available-case analysis.
Conversion of T. trichiura egg-positive participants at baseline who become egg-negative 6 and 12 months after treatment.
Outcome measures
| Measure |
Albendazole in Côte d'Ivoire
n=232 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole and Ivermectin in Côte d'Ivoire
n=234 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole in Laos
n=282 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole and Ivermectin in Laos
n=276 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole in Pemba Island
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Albendazole and Ivermectin in Pemba Island
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
|---|---|---|---|---|---|---|
|
Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) After 6 and 12 Months Post Treatment
Cured at 6 months
|
31 Participants
|
154 Participants
|
4 Participants
|
49 Participants
|
—
|
—
|
|
Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) After 6 and 12 Months Post Treatment
Cured at 12 months
|
48 Participants
|
154 Participants
|
9 Participants
|
49 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 14-21 days, 6 months and 12 months after treatmentPopulation: Overall number of participants analyzed corresponds to all participants that got randomized. An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis for each assessment time point (i.e., 14-21 days, 6 months and 12 months post-treatment).
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
Albendazole in Côte d'Ivoire
n=256 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole and Ivermectin in Côte d'Ivoire
n=255 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole in Laos
n=232 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole and Ivermectin in Laos
n=234 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole in Pemba Island
n=293 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Albendazole and Ivermectin in Pemba Island
n=288 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
|---|---|---|---|---|---|---|
|
Egg-reduction Rate (ERR) Against T. Trichiura
Geometric mean ERR at 14-21 days post treatment
|
64 percent of change
Interval 54.0 to 72.0
|
70 percent of change
Interval 61.0 to 77.0
|
69 percent of change
Interval 61.0 to 75.0
|
99 percent of change
Interval 99.0 to 99.0
|
57 percent of change
Interval 48.0 to 65.0
|
98 percent of change
Interval 98.0 to 99.0
|
|
Egg-reduction Rate (ERR) Against T. Trichiura
Geometric mean ERR at 6 months post treatment
|
—
|
—
|
79.6 percent of change
Interval 73.8 to 84.3
|
99.0 percent of change
Interval 98.6 to 99.3
|
21.2 percent of change
Interval 8.1 to 33.0
|
84.9 percent of change
Interval 80.7 to 88.2
|
|
Egg-reduction Rate (ERR) Against T. Trichiura
Geometric mean ERR at 12 months post treatmentpost treatment
|
—
|
—
|
91.3 percent of change
Interval 88.5 to 93.5
|
99.6 percent of change
Interval 99.4 to 99.7
|
53.6 percent of change
Interval 45.4 to 60.9
|
92.9 percent of change
Interval 91.0 to 94.5
|
SECONDARY outcome
Timeframe: 14-21 days, 6 months and 12 months after treatmentPopulation: Overall number of participants include all randomized participants. To assess the number of cured 14-21 days post-treatment only randomized baseline egg positive participants with follow-up stool data were considered. For the 6 and 12 month assessment all randomized participants with at least one stool sample analyzed were considered. The number cured as assessed 14-21 days post-treatment provides a proportion that is considered the cure rate (conversion rate from positive to negative).
Number of participants that converted from egg positive with Ascaris lumbricoides, hookworm and/or Strongyloides stercoralis infections to egg negative after 14-21 days. Number of egg-negatives at 6 and 12 months after treatment.
Outcome measures
| Measure |
Albendazole in Côte d'Ivoire
n=82 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole and Ivermectin in Côte d'Ivoire
n=81 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole in Laos
n=232 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole and Ivermectin in Laos
n=234 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole in Pemba Island
n=282 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Albendazole and Ivermectin in Pemba Island
n=276 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
|---|---|---|---|---|---|---|
|
Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)
Cured from Ascaris lumbricoides at 14-21 d post treatment
|
78 Participants
|
76 Participants
|
77 Participants
|
70 Participants
|
68 Participants
|
85 Participants
|
|
Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)
Egg negative for Ascaris lumbricoides 6 months post treatment
|
—
|
—
|
172 Participants
|
184 Participants
|
205 Participants
|
215 Participants
|
|
Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)
Egg negative for Ascaris lumbricoides 12 months post treatment
|
—
|
—
|
166 Participants
|
170 Participants
|
60 Participants
|
66 Participants
|
|
Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)
Cured from hookworm 14-21 d post treatment
|
27 Participants
|
15 Participants
|
100 Participants
|
115 Participants
|
40 Participants
|
28 Participants
|
|
Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)
Egg negative for hookworm 6 months post treatment
|
—
|
—
|
111 Participants
|
117 Participants
|
262 Participants
|
262 Participants
|
|
Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)
Egg negative for hookworm 12 months post treatment
|
—
|
—
|
126 Participants
|
146 Participants
|
250 Participants
|
231 Participants
|
|
Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)
Cured from Strongyloides stercoralis 14-21 d post treatment
|
—
|
—
|
18 Participants
|
21 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 14-21 days, 6 months and 12 months after treatmentPopulation: An analysis set of all randomized participants who provided any follow-up data (14-21 days, 6 or 12 months post treatment) was used to perform an available-case analysis.
Percent change in geometric mean eggs per gram of stool from before to after treatment. ERRs will be calculated for Ascaris lumbricoides and hookworm infections as described in outcome 3.
Outcome measures
| Measure |
Albendazole in Côte d'Ivoire
n=82 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole and Ivermectin in Côte d'Ivoire
n=81 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole in Laos
n=232 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole and Ivermectin in Laos
n=234 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole in Pemba Island
n=282 Participants
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Albendazole and Ivermectin in Pemba Island
n=276 Participants
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
|---|---|---|---|---|---|---|
|
Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections.
ERRs in A. lumbricoides co-infected 14-21 days post treatment
|
100 percent of change
Interval 100.0 to 100.0
|
100 percent of change
Interval 100.0 to 100.0
|
100 percent of change
Interval 100.0 to 100.0
|
100 percent of change
Interval 100.0 to 100.0
|
100 percent of change
Interval 100.0 to 100.0
|
100 percent of change
Interval 100.0 to 100.0
|
|
Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections.
Extended ERRs for A. lumbricoides 6 month post treatment
|
—
|
—
|
82.2 percent of change
Interval 66.1 to 90.9
|
75.8 percent of change
Interval 54.1 to 87.4
|
-5.7 percent of change
Interval -76.6 to 37.7
|
47.4 percent of change
Interval 6.1 to 69.5
|
|
Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections.
Extended ERRs for A. lumbricoides 12 month post treatment
|
—
|
—
|
87.3 percent of change
Interval 73.6 to 94.0
|
77.0 percent of change
Interval 52.3 to 89.0
|
25.0 percent of change
Interval -36.2 to 58.6
|
48.0 percent of change
Interval 5.1 to 70.9
|
|
Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections.
ERRs in hookworm co-infected 14-21 days post treatment
|
100 percent of change
Interval 100.0 to 100.0
|
99 percent of change
Interval 97.0 to 100.0
|
99 percent of change
Interval 98.0 to 99.0
|
99 percent of change
Interval 99.0 to 100.0
|
99 percent of change
Interval 97.0 to 100.0
|
97 percent of change
Interval 93.0 to 99.0
|
|
Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections.
Extended ERRs for hookworm 6 month post treatment
|
—
|
—
|
96.6 percent of change
Interval 94.9 to 97.7
|
97.7 percent of change
Interval 96.4 to 98.4
|
72.2 percent of change
Interval 56.3 to 84.1
|
73.2 percent of change
Interval 58.1 to 86.1
|
|
Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections.
Extended ERRs for hookworm 12 month post treatment
|
—
|
—
|
98.8 percent of change
Interval 98.1 to 99.2
|
99.2 percent of change
Interval 98.7 to 99.5
|
74.5 percent of change
Interval 57.5 to 87.0
|
59.2 percent of change
Interval 40.2 to 74.9
|
Adverse Events
Albendazole in Côte d'Ivoire
Serious events: 0 serious events
Other events: 83 other events
Deaths: 0 deaths
Albendazole and Ivermectin in Côte d'Ivoire
Serious events: 0 serious events
Other events: 99 other events
Deaths: 0 deaths
Albendazole in Laos
Serious events: 0 serious events
Other events: 77 other events
Deaths: 0 deaths
Albendazole and Ivermectin in Laos
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Albendazole in Pemba Island
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Albendazole and Ivermectin in Pemba Island
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Albendazole in Côte d'Ivoire
n=254 participants at risk
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole and Ivermectin in Côte d'Ivoire
n=254 participants at risk
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire
|
Albendazole in Laos
n=273 participants at risk
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole and Ivermectin in Laos
n=273 participants at risk
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos
|
Albendazole in Pemba Island
n=305 participants at risk
400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
Albendazole and Ivermectin in Pemba Island
n=308 participants at risk
400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
33/254 • Number of events 35 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
12.2%
31/254 • Number of events 32 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
7.3%
20/273 • Number of events 22 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
3.7%
10/273 • Number of events 10 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
4.9%
15/305 • Number of events 15 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
2.3%
7/308 • Number of events 8 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
3.5%
9/254 • Number of events 9 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
4.3%
11/254 • Number of events 11 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.00%
0/273 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.00%
0/273 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.00%
0/305 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.32%
1/308 • Number of events 1 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
13/254 • Number of events 13 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
9.8%
25/254 • Number of events 29 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
2.2%
6/273 • Number of events 6 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
1.1%
3/273 • Number of events 3 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.33%
1/305 • Number of events 1 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.00%
0/308 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
|
General disorders
Fever
|
0.00%
0/254 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
3.1%
8/254 • Number of events 8 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
3.3%
9/273 • Number of events 9 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
2.9%
8/273 • Number of events 8 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.00%
0/305 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.00%
0/308 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
|
Nervous system disorders
Headache
|
10.2%
26/254 • Number of events 29 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
12.6%
32/254 • Number of events 36 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
18.7%
51/273 • Number of events 57 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
19.0%
52/273 • Number of events 63 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
2.6%
8/305 • Number of events 8 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
2.9%
9/308 • Number of events 9 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
3/254 • Number of events 3 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
3.9%
10/254 • Number of events 10 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.73%
2/273 • Number of events 2 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.37%
1/273 • Number of events 1 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.33%
1/305 • Number of events 1 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.00%
0/308 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
|
Skin and subcutaneous tissue disorders
Itching
|
13.0%
33/254 • Number of events 37 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
17.3%
44/254 • Number of events 47 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.73%
2/273 • Number of events 2 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
2.6%
7/273 • Number of events 7 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.66%
2/305 • Number of events 2 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.32%
1/308 • Number of events 1 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
9/254 • Number of events 10 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
4.3%
11/254 • Number of events 11 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
1.5%
4/273 • Number of events 4 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
2.9%
8/273 • Number of events 8 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
1.3%
4/305 • Number of events 4 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
0.32%
1/308 • Number of events 1 • Adverse events were assessed 3h and 24h post treatment.
Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
|
Additional Information
Prof. Dr. Jennifer Keiser
Swiss Tropical and Public Health Institute
Phone: +41 (61) 284 8218
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place