Trial Outcomes & Findings for Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due to T.b. Gambiense (NCT NCT03087955)
NCT ID: NCT03087955
Last Updated: 2025-09-17
Results Overview
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 18 visit, an unfavorable outcome earlier than Month 18, or signs and symptoms evoking a relapse at Month 18. An estimate of the percentage of participants whose treatment outcome was a success at Month 18 and the 95% Jeffreys confidence interval (CI) of the estimate were provided.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
208 participants
Primary outcome timeframe
18 months post-dose
Results posted on
2025-09-17
Participant Flow
The study was conducted at Human African Trypanosomiasis (HAT) treatment centers in the Democratic Republic of Congo and Guinea. A total of 260 HAT-positive participants signed informed consent and 208 participants (167 with late- and 41 with early- and intermediate-stage HAT) were included in the study and treated. 52 participants were not included, mainly due to exclusion criteria met and/or inclusion criteria not met. Participants were enrolled between 11 October 2016 and 25 March 2019.
The pre-treatment period of up to 15 days included pre-screening, screening, and treatment of concurrent malaria/soil-transmitted helminthiasis. At the end of this period, all participants (regardless of HAT-stage) were treated with acoziborole.
Participant milestones
| Measure |
Late-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/µL for classification as intermediate stage HAT and equal to or below 5 cells/µL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
|---|---|---|
|
Overall Study
STARTED
|
167
|
41
|
|
Overall Study
COMPLETED
|
160
|
41
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
Late-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/µL for classification as intermediate stage HAT and equal to or below 5 cells/µL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
|---|---|---|
|
Overall Study
Death
|
4
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due to T.b. Gambiense
Baseline characteristics by cohort
| Measure |
Late-stage HAT
n=167 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
n=41 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/µL for classification as intermediate stage HAT and equal to or below 5 cells/µL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 11.2 • n=93 Participants
|
40.9 years
STANDARD_DEVIATION 15.0 • n=4 Participants
|
34.0 years
STANDARD_DEVIATION 12.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Sub-Saharan African
|
167 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
208 Participants
n=27 Participants
|
|
Region of Enrollment
Guinea
|
27 participants
n=93 Participants
|
7 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Region of Enrollment
Congo, The Democratic Republic of the
|
140 participants
n=93 Participants
|
34 participants
n=4 Participants
|
174 participants
n=27 Participants
|
|
White blood cells (WBC) in cerebrospinal fluid (CSF)
|
398.8 cells/µL
STANDARD_DEVIATION 438.4 • n=93 Participants
|
7.8 cells/µL
STANDARD_DEVIATION 5.3 • n=4 Participants
|
321.3 cells/µL
STANDARD_DEVIATION 422.3 • n=27 Participants
|
PRIMARY outcome
Timeframe: 18 months post-dosePopulation: The modified intention-to-treat (mITT) set included all participants who received at least 1 tablet of acoziborole, excluding participants who fled the region due to armed conflict or natural disaster or due to force majeure and for whom no failure was detected early\* and no data were available at Month 12 and Month 18.\*\* \* Parasite, need for rescue medication, death, or more than 50 WBC/μL in CSF at Month 6. \*\* Due to armed conflict, natural disaster, or force majeure affecting the site.
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 18 visit, an unfavorable outcome earlier than Month 18, or signs and symptoms evoking a relapse at Month 18. An estimate of the percentage of participants whose treatment outcome was a success at Month 18 and the 95% Jeffreys confidence interval (CI) of the estimate were provided.
Outcome measures
| Measure |
Late-stage HAT
n=167 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 18 According to Adapted World Health Organization (WHO) Criteria
|
95.2 percentage of participants
Interval 91.2 to 97.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months post-dosePopulation: The modified intention-to-treat (mITT) set included all participants who received at least 1 tablet of acoziborole, excluding participants who fled the region due to armed conflict or natural disaster or due to force majeure and for whom no failure was detected early\* and no data were available at Month 12 and Month 18.\*\* \* Parasite, need for rescue medication, death, or more than 50 WBC/μL in CSF at Month 6. \*\* Due to armed conflict, natural disaster, or force majeure affecting the site.
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 12, an unfavorable outcome earlier than end of Month 12, or signs and symptoms evoking a relapse at end of Month 12. For participants who continued after Month 12, data after Month 12 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 12 and the 95% Jeffreys CI of the estimate were provided.
Outcome measures
| Measure |
Late-stage HAT
n=167 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 12 According to Adapted WHO Criteria
|
95.8 percentage of participants
Interval 91.9 to 98.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months post-dosePopulation: The modified intention-to-treat (mITT) set included all participants who received at least 1 tablet of acoziborole, excluding participants who fled the region due to armed conflict or natural disaster or due to force majeure and for whom no failure was detected early\* and no data were available at Month 12 and Month 18.\*\* \* Parasite, need for rescue medication, death, or more than 50 WBC/μL in CSF at Month 6. \*\* Due to armed conflict, natural disaster, or force majeure affecting the site.
Success was defined according to an algorithm based on to the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 6, an unfavorable outcome earlier than end of Month 6, or signs and symptoms evoking a relapse at end of Month 6. For participants who continued after Month 6, data after Month 6 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 6 and the 95% Jeffreys CI of the estimate were provided.
Outcome measures
| Measure |
Late-stage HAT
n=167 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 6 According to Adapted WHO Criteria
|
94.6 percentage of participants
Interval 90.4 to 97.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 months post-dosePopulation: The modified intention-to-treat (mITT) set included all participants who received at least 1 tablet of acoziborole, excluding participants who fled the region due to armed conflict or natural disaster or due to force majeure and for whom no failure was detected early\* and no data were available at Month 12 and Month 18.\*\* \* Parasite, need for rescue medication, death, or more than 50 WBC/μL in CSF at Month 6. \*\* Due to armed conflict, natural disaster, or force majeure affecting the site.
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 18, an unfavorable outcome earlier than end of Month 18, or signs and symptoms evoking a relapse at end of Month 18. An estimate of the percentage of participants whose treatment outcome was a success at Month 18 and the 95% Jeffreys CI of the estimate were provided.
Outcome measures
| Measure |
Late-stage HAT
n=41 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Percentage of Participants With Early- and Intermediate-stage HAT Whose Treatment Outcome Was a Success at Month 18 According to Adapted WHO Criteria
|
100.0 percentage of participants
Interval 94.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months post-dosePopulation: The modified intention-to-treat (mITT) set included all participants who received at least 1 tablet of acoziborole, excluding participants who fled the region due to armed conflict or natural disaster or due to force majeure and for whom no failure was detected early\* and no data were available at Month 12 and Month 18.\*\* \* Parasite, need for rescue medication, death, or more than 50 WBC/μL in CSF at Month 6. \*\* Due to armed conflict, natural disaster, or force majeure affecting the site.
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 12, an unfavorable outcome earlier than end of Month 12, or signs and symptoms evoking a relapse at end of Month 12. For participants who continued after Month 12, data after Month 12 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 12 and the 95% Jeffreys CI of the estimate were provided.
Outcome measures
| Measure |
Late-stage HAT
n=41 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Percentage of Participants With Early- and Intermediate-stage HAT Whose Treatment Outcome Was a Success at Month 12 According to Adapted WHO Criteria
|
100.0 percentage of participants
Interval 94.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months post-dosePopulation: The modified intention-to-treat (mITT) set included all participants who received at least 1 tablet of acoziborole, excluding participants who fled the region due to armed conflict or natural disaster or due to force majeure and for whom no failure was detected early\* and no data were available at Month 12 and Month 18.\*\* \* Parasite, need for rescue medication, death, or more than 50 WBC/μL in CSF at Month 6. \*\* Due to armed conflict, natural disaster, or force majeure affecting the site.
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 6, an unfavorable outcome earlier than end of Month 6, or signs and symptoms evoking a relapse at end of Month 6. For participants who continued after Month 6, data after Month 6 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 6 and the 95% Jeffreys CI of the estimate were provided.
Outcome measures
| Measure |
Late-stage HAT
n=41 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Percentage of Participants With Early- and Intermediate-stage HAT Whose Treatment Outcome Was a Success at Month 6 According to Adapted WHO Criteria
|
100.0 percentage of participants
Interval 94.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 months post-dosePopulation: The modified intention-to-treat (mITT) set included all participants who received at least 1 tablet of acoziborole, excluding participants who fled the region due to armed conflict or natural disaster or due to force majeure and for whom no failure was detected early\* and no data were available at Month 12 and Month 18.\*\* \* Parasite, need for rescue medication, death, or more than 50 WBC/μL in CSF at Month 6. \*\* Due to armed conflict, natural disaster, or force majeure affecting the site.
Failure was defined as the first objective evidence of proven and definitive (sustainable) failure, defined as death; rescue medication use; trypanosomes in any body fluid at Month 6, 12, or 18; a cerebrospinal fluid (CSF) white blood cell count (WBC) of \>50 cells/μL at Month 6 followed by confirmation of failure (defined as CSF WBC \>20 cells/μL at Month 12 and/or Month 18 and/or signs and symptoms evoking a relapse at Month 12 and/or Month 18); a CSF WBC \>20 cells/μL at Month 12 followed by confirmation of failure (defined as CSF WBC \>20 cells/μL at Month 18 and/or signs and symptoms evoking a relapse at Month 18); or a CSF WBC \>20 cells/μL at Month 18. This outcome was analyzed using a Kaplan-Meier approach to estimate the cumulative rate of proven and definitive failures. The proven failure-free probability was estimated as an alternative (more liberal) success rate (95% CI) at Month 18 based on the Kaplan-Meier estimate of the rate of participants who were not proven failures
Outcome measures
| Measure |
Late-stage HAT
n=167 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Estimated Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was Not a Proven Failure at Month 18, Based on the Kaplan-Meier Analysis of Time to Proven and Definitive Failure
|
96.0 percentage of participants
Interval 91.0 to 98.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From the single dose acoziborole administration until 6 months post-dose for non-serious AEs and 18 months post-dose for serious AEsPopulation: The Treated set included all participants who received at least one tablet of acoziborole.
Occurrence of any AEs, during the observation period and until 6 months post-dose (for non-serious AEs) and until 18 months post-dose for SAEs. Analysis of AEs was based on the concept of TEAEs, defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
Outcome measures
| Measure |
Late-stage HAT
n=167 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
n=41 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
n=208 Participants
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
127 Participants
|
28 Participants
|
155 Participants
|
SECONDARY outcome
Timeframe: From the single dose acoziborole administration until 18 months post-dosePopulation: The Treated set included all participants who received at least one tablet of acoziborole.
Occurrence of any serious TEAEs during the observation period and until 18 months post-dose.
Outcome measures
| Measure |
Late-stage HAT
n=167 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
n=41 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
n=208 Participants
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Number of Participants With Serious TEAEs
|
18 Participants
|
3 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and 4, 9, 24, 48, 72, 96, and 240 hours post-dosePopulation: The pharmacokinetic (PK) analysis set included participants who received an oral dose of 960 mg acoziborole, as far as the information about time and amount was available, and for whom at least one blood sample for PK was available.
Participants received a single dose of 960 mg acoziborole on Day 1. Acoziborole in whole blood was assessed pre-dose and 4, 9, 24, 48, 72, 96, and 240 hours after the single administration, (on Days 1, 2, 3, 4, 5, and 11). Data up to 240 hours post dose were considered for this analysis. Descriptive statistics of the AUC0-240h were presented. The activity of acoziborole is more exposure-dependent than concentration-dependent, therefore the exposure (AUC) was used as the main PK data for efficacy purposes.
Outcome measures
| Measure |
Late-stage HAT
n=167 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
n=41 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
n=208 Participants
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Acoziborole Area Under the Curve From Time Zero to 240 Hours Post Dose (AUC0-240h) in Whole Blood Considering Concentration-time Data up to 240 Hours After a Single Administration
|
2217617.78 h*ng/mL
Standard Deviation 647696.87
|
2051104.88 h*ng/mL
Standard Deviation 485620.67
|
2184795.53 h*ng/mL
Standard Deviation 621610.31
|
SECONDARY outcome
Timeframe: 240 hours post-dosePopulation: The PK analysis set included participants who received an oral dose of 960 mg acoziborole, as far as the information about time and amount was available, and for whom at least one blood sample for PK was available.
Participants received a single dose of 960 mg acoziborole on Day 1. Acoziborole in CSF of participants with late-stage HAT was assessed 240 hours after the single administration (on Day 11). Descriptive statistics of the acoziborole concentration were presented.
Outcome measures
| Measure |
Late-stage HAT
n=129 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Mean Acoziborole Concentration in CSF After 240 Hours in Participants With Late-stage HAT
|
100.8 ng/mL
Standard Deviation 63.968
|
—
|
—
|
SECONDARY outcome
Timeframe: 240 hours post-dosePopulation: The PK analysis set included participants who received an oral dose of 960 mg acoziborole, as far as the information about time and amount was available, and for whom at least one blood sample for PK was available.
Participants received a single dose of 960 mg acoziborole on Day 1. Acoziborole in CSF of participants with early- and intermediate-stage HAT was assessed 240 hours after the single administration (on Day 11). Descriptive statistics of the acoziborole concentration were presented.
Outcome measures
| Measure |
Late-stage HAT
n=31 Participants
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Early- and Intermediate-stage HAT
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/μL for classification as intermediate stage HAT and equal to or below 5 cells/μL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Acoziborole: Acoziborole 960 mg as a single oral dose (3 x 320 mg tablets; fasted state)
|
Any Stage HAT
Participants with any stage HAT, including all participants irrespective of HAT stage (participants with late-stage HAT and participants with early- and intermediate-stage HAT). Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|---|
|
Mean Acoziborole Concentration in CSF After 240 Hours in Participants With Early- and Intermediate-stage HAT
|
81.4 ng/mL
Standard Deviation 48.5
|
—
|
—
|
Adverse Events
Late-stage HAT
Serious events: 18 serious events
Other events: 127 other events
Deaths: 4 deaths
Early- and Intermediate-stage HAT
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Late-stage HAT
n=167 participants at risk
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
|
Early- and Intermediate-stage HAT
n=41 participants at risk
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/µL for classification as intermediate stage HAT and equal to or below 5 cells/µL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|
|
Infections and infestations
Malaria
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Appendicitis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Extrapulmonary tuberculosis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Gastroenteritis
|
0.60%
1/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Puerperal infection
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Systemic infection
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Typhoid fever
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Acute psychosis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Brief psychotic disorder with marked stressors
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Major depression
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Mania
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Organic brain syndrome
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Suicide attempt
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord prolapse
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
Other adverse events
| Measure |
Late-stage HAT
n=167 participants at risk
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
|
Early- and Intermediate-stage HAT
n=41 participants at risk
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/µL for classification as intermediate stage HAT and equal to or below 5 cells/µL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
6/167 • Number of events 6 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.4%
4/167 • Number of events 4 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Cardiac disorders
Bradycardia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Cardiac disorders
Chest pain
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Cardiac disorders
Tachycardia
|
0.60%
1/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Eye disorders
Eye pruritus
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Eye disorders
Ocular hyperaemia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Eye disorders
Vision blurred
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
8/167 • Number of events 9 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
3/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Eructation
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
5/167 • Number of events 5 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
13/167 • Number of events 14 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
General disorders
Asthenia
|
7.8%
13/167 • Number of events 14 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
12.2%
5/41 • Number of events 5 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
General disorders
Chest pain
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
General disorders
Chills
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
General disorders
Feeling hot
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
General disorders
Gait disturbance
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
General disorders
Influenza like illness
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
General disorders
Oedema peripheral
|
1.8%
3/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
General disorders
Pyrexia
|
16.2%
27/167 • Number of events 30 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
9.8%
4/41 • Number of events 4 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Abscess
|
1.8%
3/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Acarodermatitis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Appendicitis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Bronchitis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Conjunctivitis
|
1.8%
3/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Diarrhoea infectious
|
3.0%
5/167 • Number of events 6 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
4.9%
2/41 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Dysentery
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Enteritis infectious
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Filariasis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Gastroenteritis
|
2.4%
4/167 • Number of events 5 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Helminthic infection
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Infection parasitic
|
1.8%
3/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Infectious colitis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Influenza
|
1.8%
3/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Malaria
|
13.2%
22/167 • Number of events 27 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
12.2%
5/41 • Number of events 5 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Onychomycosis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Paronychia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Respiratory tract infection
|
1.8%
3/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Schistosomiasis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Skin infection
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Syphilis
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Typhoid fever
|
2.4%
4/167 • Number of events 4 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
7/167 • Number of events 10 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Varicella
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.0%
5/167 • Number of events 5 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Infections and infestations
Wound infection
|
1.8%
3/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
12.6%
21/167 • Number of events 22 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
26.8%
11/41 • Number of events 13 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
23.4%
39/167 • Number of events 46 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
31.7%
13/41 • Number of events 17 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
4.9%
2/41 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Investigations
Blood creatinine increased
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Investigations
Blood glucose increased
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Investigations
Blood potassium increased
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Investigations
Blood sodium decreased
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Investigations
Weight decreased
|
3.6%
6/167 • Number of events 6 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Investigations
Weight increased
|
11.4%
19/167 • Number of events 19 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
4/167 • Number of events 4 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
4.9%
2/41 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Metabolism and nutrition disorders
Obesity
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Metabolism and nutrition disorders
Overweight
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
4/167 • Number of events 4 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
10/167 • Number of events 11 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
7.3%
3/41 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
4/167 • Number of events 4 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Dizziness
|
1.8%
3/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Dyskinesia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Formication
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Headache
|
23.4%
39/167 • Number of events 49 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
29.3%
12/41 • Number of events 14 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Motor dysfunction
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Paraesthesia
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Seizure
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Somnolence
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Syncope
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Nervous system disorders
Tremor
|
3.6%
6/167 • Number of events 7 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Abnormal behaviour
|
3.6%
6/167 • Number of events 6 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Anxiety
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Bulimia nervosa
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Delirium
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Eating disorder
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Enuresis
|
1.2%
2/167 • Number of events 5 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Insomnia
|
7.8%
13/167 • Number of events 16 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
4.9%
2/41 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Psychiatric disorders
Psychotic disorder
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Renal and urinary disorders
Chromaturia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Renal and urinary disorders
Pollakiuria
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Renal and urinary disorders
Proteinuria
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
4.9%
2/41 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.2%
2/167 • Number of events 2 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
7/167 • Number of events 7 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/167 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.2%
2/167 • Number of events 3 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Vascular disorders
Hypertension
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
2.4%
1/41 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Vascular disorders
Hypotension
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
|
Vascular disorders
Orthostatic hypotension
|
0.60%
1/167 • Number of events 1 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
0.00%
0/41 • Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
The Investigator collected all AEs observed directly and those reported spontaneously. AEs and serious AEs were defined according to standard definitions. In specific, in this study, alanine aminotransferase or aspartic aminotransferase levels 3 times above the upper limit of normal (ULN) accompanied by total bilirubin levels 2 times above the ULN were considered serious AEs. Furthermore, any suspected transmission of an infectious agent via a medicinal product was also considered a serious AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor authorizes publications by a single site provided that multicentric results are published beforehand and any communication is submitted to the sponsor for review at least 28 days before the expected publication date. The sponsor can comment for 28 days. Upon sponsor request, any confidential information will have to be removed before publishing. Publishing can be postponed by 90 additional days, should the sponsor want to protect data through a patent application or any other mean.
- Publication restrictions are in place
Restriction type: OTHER