Trial Outcomes & Findings for Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients (NCT NCT00991510)
NCT ID: NCT00991510
Last Updated: 2018-11-08
Results Overview
Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 6 hours).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Results posted on
2018-11-08
Participant Flow
A total of 100 subjects were planned. A total of 47 subjects were screened in the study. Four subjects were not randomised, i.e., two subjects withdrew consent, one subject had a protocol violation, and one subject was a screening failure (did not meet eligibility criteria).
Participant milestones
| Measure |
Reference/Test/Test
The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Test/Reference/Reference
The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
|---|---|---|
|
Period I (Days 1-14)
STARTED
|
22
|
21
|
|
Period I (Days 1-14)
COMPLETED
|
21
|
21
|
|
Period I (Days 1-14)
NOT COMPLETED
|
1
|
0
|
|
Period II (Days 15-28)
STARTED
|
21
|
21
|
|
Period II (Days 15-28)
COMPLETED
|
21
|
21
|
|
Period II (Days 15-28)
NOT COMPLETED
|
0
|
0
|
|
Period III (Days 29-112)
STARTED
|
21
|
21
|
|
Period III (Days 29-112)
COMPLETED
|
20
|
20
|
|
Period III (Days 29-112)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Reference/Test/Test
The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Test/Reference/Reference
The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
|---|---|---|
|
Period I (Days 1-14)
Adverse Event
|
1
|
0
|
|
Period III (Days 29-112)
Adverse Event
|
1
|
1
|
Baseline Characteristics
Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
Reference/Test/Test
n=22 Participants
The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Test/Reference/Reference
n=21 Participants
The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 13.55 • n=7 Participants
|
50.7 years
STANDARD_DEVIATION 13.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Height
|
1.711 meters
STANDARD_DEVIATION 0.1061 • n=5 Participants
|
1.718 meters
STANDARD_DEVIATION 0.0983 • n=7 Participants
|
1.714 meters
STANDARD_DEVIATION 0.1012 • n=5 Participants
|
|
Weight
|
77.19 kilograms
STANDARD_DEVIATION 14.856 • n=5 Participants
|
77.23 kilograms
STANDARD_DEVIATION 15.661 • n=7 Participants
|
77.21 kilograms
STANDARD_DEVIATION 15.072 • n=5 Participants
|
|
Body Mass Index
|
26.24 kg/m^2
STANDARD_DEVIATION 3.756 • n=5 Participants
|
25.93 kg/m^2
STANDARD_DEVIATION 3.422 • n=7 Participants
|
26.09 kg/m^2
STANDARD_DEVIATION 3.557 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administrationPopulation: PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 6 hours).
Outcome measures
| Measure |
CellCept
n=41 Participants
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=41 Participants
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC(0-6h)) of Mycophenolate Mofetil
|
33.523 hour* µg /ml
Standard Deviation 15.1265
|
31.100 hour* µg /ml
Standard Deviation 15.4198
|
—
|
PRIMARY outcome
Timeframe: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administrationPopulation: PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
For participants with a 0-12h profile: Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 12 hours). For participants with a 0-6h profile: AUC(0-tau) was calculated based on AUC(0-6h) using the extrapolation formula according to Fleming.
Outcome measures
| Measure |
CellCept
n=41 Participants
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=41 Participants
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC(0-tau)) of Mycophenolate Mofetil
|
49.846 hour* µg /ml
Standard Deviation 20.8278
|
48.255 hour* µg /ml
Standard Deviation 21.2246
|
—
|
PRIMARY outcome
Timeframe: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administrationPopulation: PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Cmax was directly obtained from measured values of plasma concentrations.
Outcome measures
| Measure |
CellCept
n=41 Participants
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=41 Participants
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Mycophenolate Mofetil
|
16.189 µg /ml
Standard Deviation 9.9448
|
14.308 µg /ml
Standard Deviation 8.3432
|
—
|
SECONDARY outcome
Timeframe: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administrationPopulation: PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Cmin was directly obtained from measured values of plasma concentrations.
Outcome measures
| Measure |
CellCept
n=41 Participants
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=41 Participants
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of Mycophenolate Mofetil
|
1.584 µg /ml
Standard Deviation 0.7801
|
1.567 µg /ml
Standard Deviation 0.7387
|
—
|
SECONDARY outcome
Timeframe: Day 14 and Day 28 (end of first two cross-over periods) before drug administrationPopulation: PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Cpd was directly obtained from measured values of plasma concentrations.
Outcome measures
| Measure |
CellCept
n=41 Participants
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=41 Participants
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Plasma Concentrations of Mycophenolate Mofetil in Pre-Administration Samples (Cpd)
|
2.693 µg /ml
Standard Deviation 1.7001
|
3.001 µg /ml
Standard Deviation 2.0863
|
—
|
SECONDARY outcome
Timeframe: Day 14 and Day 28 (end of first two cross-over periods) before drug administrationPopulation: PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
PTF was calculated as: (Cmax-Cmin)/(AUCt/t)\*100
Outcome measures
| Measure |
CellCept
n=41 Participants
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=41 Participants
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Degree of Fluctuation of the Concentration Levels of Mycophenolate Mofetil Over One Dosing Interval (PTF)
|
351.05 percentage of AUC for a dosing interval
Standard Deviation 161.195
|
323.67 percentage of AUC for a dosing interval
Standard Deviation 156.018
|
—
|
SECONDARY outcome
Timeframe: Day 14 and Day 28 (end of first two cross-over periods) before drug administrationPopulation: PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Tmax was directly obtained from measured values.
Outcome measures
| Measure |
CellCept
n=41 Participants
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=41 Participants
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Time Corresponding to Occurrence of Cmax (Tmax) of Mycophenolate Mofetil
|
1.119 hours
Standard Deviation 0.7462
|
1.344 hours
Standard Deviation 1.1439
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 112Population: Safety population. One participant discontinued the study prior to Period II so the Myfenax # participants analyzed is one less than the CellCept arm.
Summary of adverse events across three study time periods. The on-treatment time frame spanned the time during which study drug was administered. Relation to study drug was assessed by the investigator. The Adverse Event count includes serious and non-serious AEs. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above. Severity was measured on a three-point scale: mild, moderate, severe.
Outcome measures
| Measure |
CellCept
n=43 Participants
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=42 Participants
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
n=43 Participants
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Summary of Participants With Adverse Events
Adverse Events
|
15 participants
|
17 participants
|
26 participants
|
|
Summary of Participants With Adverse Events
Related adverse events
|
3 participants
|
7 participants
|
9 participants
|
|
Summary of Participants With Adverse Events
Severe adverse events
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Participants With Adverse Events
Adverse events leading to discontinuation
|
2 participants
|
1 participants
|
3 participants
|
|
Summary of Participants With Adverse Events
Serious adverse events
|
1 participants
|
1 participants
|
1 participants
|
|
Summary of Participants With Adverse Events
Adverse events leading to death
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
CellCept
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Myfenax
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Overall
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CellCept
n=43 participants at risk
Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=42 participants at risk
Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
n=43 participants at risk
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Cardiac disorders
Cardiac failure
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
Other adverse events
| Measure |
CellCept
n=43 participants at risk
Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Myfenax
n=42 participants at risk
Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
|
Overall
n=43 participants at risk
Participant experience overall, i.e. all treatment experiences while on study are included
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
2/43 • Day 1 up to Day 112
|
11.9%
5/42 • Day 1 up to Day 112
|
14.0%
6/43 • Day 1 up to Day 112
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43 • Day 1 up to Day 112
|
4.8%
2/42 • Day 1 up to Day 112
|
7.0%
3/43 • Day 1 up to Day 112
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43 • Day 1 up to Day 112
|
4.8%
2/42 • Day 1 up to Day 112
|
4.7%
2/43 • Day 1 up to Day 112
|
|
General disorders
Oedema peripheral
|
4.7%
2/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
4.7%
2/43 • Day 1 up to Day 112
|
|
Infections and infestations
Herpes simplex
|
4.7%
2/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
4.7%
2/43 • Day 1 up to Day 112
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
2/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
4.7%
2/43 • Day 1 up to Day 112
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/43 • Day 1 up to Day 112
|
4.8%
2/42 • Day 1 up to Day 112
|
4.7%
2/43 • Day 1 up to Day 112
|
|
Investigations
Blood pressure increased
|
4.7%
2/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
4.7%
2/43 • Day 1 up to Day 112
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/43 • Day 1 up to Day 112
|
4.8%
2/42 • Day 1 up to Day 112
|
4.7%
2/43 • Day 1 up to Day 112
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • Day 1 up to Day 112
|
7.1%
3/42 • Day 1 up to Day 112
|
7.0%
3/43 • Day 1 up to Day 112
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
2/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
4.7%
2/43 • Day 1 up to Day 112
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Eye disorders
Conjunctivitis allergic
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Gastrointestinal disorders
Periodontitis
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Gastrointestinal disorders
Rectal discharge
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
General disorders
Application site erythema
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
General disorders
Chills
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Infections and infestations
Bronchitis
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Infections and infestations
Rhinitis
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Investigations
Blood triglycerides increased
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Investigations
Cardiac murmur
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowenoid papulosis
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Nervous system disorders
Tremor
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Psychiatric disorders
Depression
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
2.3%
1/43 • Day 1 up to Day 112
|
0.00%
0/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
|
Vascular disorders
Hypertension
|
0.00%
0/43 • Day 1 up to Day 112
|
2.4%
1/42 • Day 1 up to Day 112
|
2.3%
1/43 • Day 1 up to Day 112
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER