Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study) (NCT NCT01136954)
NCT ID: NCT01136954
Last Updated: 2016-01-25
Results Overview
Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event with a start date on or after Day 1 and within 15 days of last dose. For each event, each participant experiencing an event is only counted once even if they had multiple episodes.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
Week 1 through Week 59
Results posted on
2016-01-25
Participant Flow
Subjects who completed E2090-E044-312 (NCT00566254)"Study 312" core study were invited to participate in this extension study.
Participant milestones
| Measure |
Zonisamide(Placebo During Core Study)
Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
|
Zonisamide (Zonisamide During Core Study)
Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
24
|
21
|
Reasons for withdrawal
| Measure |
Zonisamide(Placebo During Core Study)
Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
|
Zonisamide (Zonisamide During Core Study)
Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Lack of Efficacy
|
14
|
13
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Other
|
1
|
3
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)
Baseline characteristics by cohort
| Measure |
Zonisamide(Placebo During Core Study)
n=72 Participants
Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
|
Zonisamide (Zonisamide During Core Study)
n=72 Participants
Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
6-11 Years
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Age, Customized
12-18 Years
|
38 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 1 through Week 59Population: Safety Population (all subjects who entered the study and received at least one dose of study drug)
Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event with a start date on or after Day 1 and within 15 days of last dose. For each event, each participant experiencing an event is only counted once even if they had multiple episodes.
Outcome measures
| Measure |
Zonisamide (Placebo During Core Study)
n=72 Participants
Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
|
Zonisamide (Zonisamide During Core Study)
n=72 Participants
Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
|
|---|---|---|
|
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency
Nasopharyngitis
|
6 Participants
|
9 Participants
|
|
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency
Bronchitis
|
4 Participants
|
3 Participants
|
|
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency
Respiratory tract infection
|
2 Participants
|
4 Participants
|
|
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency
Headache
|
4 Participants
|
7 Participants
|
|
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency
Weight decreased
|
6 Participants
|
6 Participants
|
|
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency
Abdominal pain
|
1 Participants
|
4 Participants
|
|
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency
Decreased Appetite
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 59Population: Safety Population
A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants'parent or guardian maintained a seizure diary recording the date,number, and type of seizures the subject had. The primary analysis assessed the percent of responders from baseline in the Open Label Visit Period. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.
Outcome measures
| Measure |
Zonisamide (Placebo During Core Study)
n=72 Participants
Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
|
Zonisamide (Zonisamide During Core Study)
n=72 Participants
Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
|
|---|---|---|
|
Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Open Label Period
|
55.6 Percentage of Participants
|
56.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313Population: Safety Population
Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period.
Outcome measures
| Measure |
Zonisamide (Placebo During Core Study)
n=72 Participants
Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
|
Zonisamide (Zonisamide During Core Study)
n=72 Participants
Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
|
|---|---|---|
|
Median Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period
|
-3.8 Seizures
Interval -89.0 to 73.0
|
-4.7 Seizures
Interval -95.0 to 50.0
|
SECONDARY outcome
Timeframe: Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313Population: Safety Population
Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period. Percentage change = 100% x (seizure frequency at period - seizure frequency at Study 312 baseline)/seizure frequency at Study 312 baseline.
Outcome measures
| Measure |
Zonisamide (Placebo During Core Study)
n=72 Participants
Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
|
Zonisamide (Zonisamide During Core Study)
n=72 Participants
Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
|
|---|---|---|
|
Median Percent Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period
|
-64.6 Percentage Change
Interval -100.0 to 174.0
|
-67.9 Percentage Change
Interval -100.0 to 262.0
|
Adverse Events
Zonisamide(Placebo During Core Study)
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Zonisamide (Zonisamide During Core Study)
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zonisamide(Placebo During Core Study)
n=72 participants at risk
Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
|
Zonisamide (Zonisamide During Core Study)
n=72 participants at risk
Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Infections and infestations
Lymph gland infection
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Infections and infestations
Pneumonia
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Infections and infestations
Viral infection
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Respiratory, thoracic and mediastinal disorders
Foreign body aspiration
|
0.00%
0/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
Other adverse events
| Measure |
Zonisamide(Placebo During Core Study)
n=72 participants at risk
Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
|
Zonisamide (Zonisamide During Core Study)
n=72 participants at risk
Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.3%
6/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
12.5%
9/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Infections and infestations
Bronchitis
|
5.6%
4/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
4.2%
3/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Infections and infestations
Respiratory tract infection
|
2.8%
2/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
5.6%
4/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Nervous system disorders
Headache
|
5.6%
4/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
9.7%
7/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Investigations
Weight decreased
|
8.3%
6/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
8.3%
6/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
5.6%
4/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.9%
5/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
5.6%
4/72 • "Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 61 weeks.
Treatment-emergent AEs were summarized by period (Transition, Open-label, Down-titration), treatment group,body system, and preferred term (PT).
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place