Trial Outcomes & Findings for Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia (NCT NCT02012959)
NCT ID: NCT02012959
Last Updated: 2018-09-26
Results Overview
Change in serum sodium concentration (mEq/L) for responders from Day 2 (or Day 2a) at the end of Treatment Phase A (where all participants received tolvaptan) to the end of Treatment Phase B for the Early compared to Late Withdrawal groups is reported. Once a participant was randomized to Treatment Phase B, any additional therapies for the purpose of raising serum sodium, including fluid restriction, were considered rescue therapy. Upon receipt of rescue therapy, a participant's endpoint data was collected and then censored from the efficacy analysis thereafter, unless specified.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
Day 2/2a, Day 4
Results posted on
2018-09-26
Participant Flow
Participant milestones
| Measure |
Treatment Phase A
During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 milliequivalent (mEq)/liter (L) by Day 2, treatment was extended one additional day (Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders.
|
Treatment Phase B: Responder - Late Withdrawal
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
|
Treatment Phase B: Responder - Early Withdrawal
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
|
Treatment Phase B: Non-responder - Study Drug
Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion and continued tolvaptan for Days 3 and 4.
|
Treatment Phase B: Non-responder - Standard of Care
Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion. The participants in this arm discontinued tolvaptan and received the investigator's preferred standard of care for Days 3 and 4.
|
|---|---|---|---|---|---|
|
Treatment Phase A
STARTED
|
9
|
0
|
0
|
0
|
0
|
|
Treatment Phase A
Received At Least 1 Dose of Study Drug
|
9
|
0
|
0
|
0
|
0
|
|
Treatment Phase A
COMPLETED
|
7
|
0
|
0
|
0
|
0
|
|
Treatment Phase A
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
|
Treatment Phase B
STARTED
|
0
|
2
|
3
|
1
|
1
|
|
Treatment Phase B
Received At Least 1 Dose of Study Drug
|
0
|
2
|
3
|
1
|
1
|
|
Treatment Phase B
COMPLETED
|
0
|
2
|
3
|
1
|
1
|
|
Treatment Phase B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Phase A
During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 milliequivalent (mEq)/liter (L) by Day 2, treatment was extended one additional day (Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders.
|
Treatment Phase B: Responder - Late Withdrawal
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
|
Treatment Phase B: Responder - Early Withdrawal
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
|
Treatment Phase B: Non-responder - Study Drug
Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion and continued tolvaptan for Days 3 and 4.
|
Treatment Phase B: Non-responder - Standard of Care
Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion. The participants in this arm discontinued tolvaptan and received the investigator's preferred standard of care for Days 3 and 4.
|
|---|---|---|---|---|---|
|
Treatment Phase A
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
Baseline characteristics by cohort
| Measure |
Treatment Phase A
n=9 Participants
During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 mEq/L by Day 2, treatment was extended one additional day (Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders. Participants who were responders (serum sodium increased by ≥4 mEq/L) continued to Treatment Phase B (Randomization Phase) on Day 3.
|
|---|---|
|
Age, Continuous
|
6.1 years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 2/2a, Day 4Population: Treatment Phase B Responders: full analysis dataset comprised of all participants in the Phase B Safety Sample with both baseline and at least 1 postrandomization serum sodium evaluation in Phase B.
Change in serum sodium concentration (mEq/L) for responders from Day 2 (or Day 2a) at the end of Treatment Phase A (where all participants received tolvaptan) to the end of Treatment Phase B for the Early compared to Late Withdrawal groups is reported. Once a participant was randomized to Treatment Phase B, any additional therapies for the purpose of raising serum sodium, including fluid restriction, were considered rescue therapy. Upon receipt of rescue therapy, a participant's endpoint data was collected and then censored from the efficacy analysis thereafter, unless specified.
Outcome measures
| Measure |
Responder - Late Withdrawal
n=2 Participants
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
|
Responder - Early Withdrawal
n=3 Participants
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
|
|---|---|---|
|
Change In Serum Sodium Concentration For Responders
|
-4.0 mEq/L
Standard Deviation 4.2
|
-1.0 mEq/L
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, Day 2/2aPopulation: Treatment Phase A: all participants in the Phase A Safety Sample and who had baseline and at least 1 postbaseline serum sodium evaluation in Phase A.
Change in serum sodium concentration (mEq/L) from baseline to the end of Day 2 (or 2a) during Treatment Phase A for all participants (responders and non-responders) is reported.
Outcome measures
| Measure |
Responder - Late Withdrawal
n=9 Participants
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
|
Responder - Early Withdrawal
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
|
|---|---|---|
|
Change In Serum Sodium Concentration During Treatment Phase A
Day 1: 24 hours Post Dose
|
1 mEq/L
Standard Deviation 3
|
—
|
|
Change In Serum Sodium Concentration During Treatment Phase A
Day 2: 24 hours Post Dose
|
3.4 mEq/L
Standard Deviation 4.8
|
—
|
|
Change In Serum Sodium Concentration During Treatment Phase A
Day 2a: 24 hours Post Dose
|
2.3 mEq/L
Standard Deviation 2.1
|
—
|
SECONDARY outcome
Timeframe: Every 6 hours on Days 1 and 2Population: Treatment Phase A: all participants in the Phase A Safety Sample and who had baseline and at least 1 postbaseline serum sodium evaluation in Phase A.
Every 6 hours and for the 24-hour daily interval on Days 1 and 2 during Treatment Phase A, fluid balance (milliliters \[mL\]) was determined by fluid intake (oral and intravenous) minus urine output. Improved fluid balance would be indicated through the induction of increased urine volume. Fluid balance was monitored per institutional guidelines.
Outcome measures
| Measure |
Responder - Late Withdrawal
n=9 Participants
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
|
Responder - Early Withdrawal
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
|
|---|---|---|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 1: 0-6 hours
|
-1 mL
Standard Deviation 505
|
—
|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 1: 6-12 hours
|
-261 mL
Standard Deviation 533
|
—
|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 1: 12-18 hours
|
-36 mL
Standard Deviation 253
|
—
|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 1: 18-24 hours
|
31 mL
Standard Deviation 344
|
—
|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 1: 0-24 hours
|
-268 mL
Standard Deviation 849
|
—
|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 2: 0-6 hours
|
-101 mL
Standard Deviation 376
|
—
|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 2: 6-12 hours
|
6 mL
Standard Deviation 513
|
—
|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 2: 12-18 hours
|
-45 mL
Standard Deviation 400
|
—
|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 2: 18-24 hours
|
-21 mL
Standard Deviation 191
|
—
|
|
Fluid Balance (Intake Minus Output) During Treatment Phase A
Day 2: 0-24 hours
|
-160 mL
Standard Deviation 733
|
—
|
Adverse Events
Treatment Phase A
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment Phase B: Responder - Late Withdrawal
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Phase B: Responder - Early Withdrawal
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment Phase B: Non-responder - Study Drug
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Phase B: Non-responder - Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Phase A
n=9 participants at risk
During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 mEq/L by Day 2, treatment was extended one additional day (to Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders.
|
Treatment Phase B: Responder - Late Withdrawal
n=2 participants at risk
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
|
Treatment Phase B: Responder - Early Withdrawal
n=3 participants at risk
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
|
Treatment Phase B: Non-responder - Study Drug
n=1 participants at risk
Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion and continued tolvaptan for Days 3 and 4.
|
Treatment Phase B: Non-responder - Standard of Care
n=1 participants at risk
Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion. The participants in this arm discontinued tolvaptan and received the investigator's preferred standard of care for Days 3 and 4.
|
|---|---|---|---|---|---|
|
General disorders
Catheter site extravasation
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
100.0%
1/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
General disorders
Medical device site haemorrhage
|
11.1%
1/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
50.0%
1/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Gastrointestinal disorders
Faecal volume increased
|
11.1%
1/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
Other adverse events
| Measure |
Treatment Phase A
n=9 participants at risk
During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 mEq/L by Day 2, treatment was extended one additional day (to Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders.
|
Treatment Phase B: Responder - Late Withdrawal
n=2 participants at risk
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
|
Treatment Phase B: Responder - Early Withdrawal
n=3 participants at risk
Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
|
Treatment Phase B: Non-responder - Study Drug
n=1 participants at risk
Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion and continued tolvaptan for Days 3 and 4.
|
Treatment Phase B: Non-responder - Standard of Care
n=1 participants at risk
Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion. The participants in this arm discontinued tolvaptan and received the investigator's preferred standard of care for Days 3 and 4.
|
|---|---|---|---|---|---|
|
Investigations
Blood sodium decreased
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
100.0%
1/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
33.3%
1/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
33.3%
1/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
100.0%
1/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
100.0%
1/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
50.0%
1/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
100.0%
1/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
General disorders
Pyrexia
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
33.3%
1/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
3/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
33.3%
1/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
100.0%
1/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
100.0%
1/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
100.0%
1/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • From screening through early termination or follow-up phase (14 days postrandomization).
|
50.0%
1/2 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/3 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
0.00%
0/1 • From screening through early termination or follow-up phase (14 days postrandomization).
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: +1-609-524-6788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right to review, edit, and authorize publications.
- Publication restrictions are in place
Restriction type: OTHER