Trial Outcomes & Findings for The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection (NCT NCT00556504)
NCT ID: NCT00556504
Last Updated: 2014-08-07
Results Overview
SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment.. 1. A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72. 2. If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value. 3. If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable. Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Results posted on
2014-08-07
Participant Flow
recruitment period: 12 Months location: CGMH clinical ceters
Participant milestones
| Measure |
TCM-700C
TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
Placebo
Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
Intend-to Treat Population
|
42
|
42
|
|
Overall Study
Safety Population
|
41
|
42
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
Baseline characteristics by cohort
| Measure |
TCM-700C
n=42 Participants
TCM-700C, an add-on drug to conventional treatment of Hepatitis C
|
Placebo
n=42 Participants
Placebo with convetional treatment for HCV patients
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 9.58 • n=99 Participants
|
48.74 years
STANDARD_DEVIATION 11.52 • n=107 Participants
|
48.67 years
STANDARD_DEVIATION 10.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
42 participants
n=99 Participants
|
42 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Fibrosis score
Fibrosis score 0
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Fibrosis score
Fibrosis score 1
|
11 participants
n=99 Participants
|
21 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Fibrosis score
Fibrosis score 2
|
31 participants
n=99 Participants
|
19 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment.. 1. A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72. 2. If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value. 3. If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable. Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)
Outcome measures
| Measure |
TCM-700C
n=42 Participants
TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
Placebo
n=42 Participants
Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
|---|---|---|
|
Sustained Virologic Response (SVR)
|
27 Number of participants with SVR
|
29 Number of participants with SVR
|
SECONDARY outcome
Timeframe: at the end of combination drug treatment (up to 48 weeks)undetectable HCV RNA at the end of combination drug treatment Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit).
Outcome measures
| Measure |
TCM-700C
n=42 Participants
TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
Placebo
n=42 Participants
Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
|---|---|---|
|
Virologic Response
|
34 participants
|
31 participants
|
SECONDARY outcome
Timeframe: at the end of combination drug treatment (up to 48 weeks)An ALT response is defined as normalization of ALT at the end of combination drug treatment. (ALT normalization is defined as ALT level decreases into within the normal range)
Outcome measures
| Measure |
TCM-700C
n=42 Participants
TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
Placebo
n=42 Participants
Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
|---|---|---|
|
ALT Response
|
32 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.
Outcome measures
| Measure |
TCM-700C
n=42 Participants
TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
Placebo
n=42 Participants
Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
|---|---|---|
|
Sustained ALT Response
|
26 participants
|
27 participants
|
SECONDARY outcome
Timeframe: at the end of combination drug treatment (up to 48 weeks)Combined ALT and virologic response at the end of combination drug treatment.
Outcome measures
| Measure |
TCM-700C
n=42 Participants
TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
Placebo
n=42 Participants
Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
|---|---|---|
|
Combined ALT and Virologic Response
|
31 participants
|
29 participants
|
SECONDARY outcome
Timeframe: at the end of combination drug treatment (up to 48 weeks)Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment (Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)
Outcome measures
| Measure |
TCM-700C
n=42 Participants
TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
Placebo
n=42 Participants
Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
|---|---|---|
|
Immune Cell Normalization
CD4
|
31 participants
|
27 participants
|
|
Immune Cell Normalization
CD8
|
36 participants
|
31 participants
|
|
Immune Cell Normalization
NK cells
|
37 participants
|
31 participants
|
SECONDARY outcome
Timeframe: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.
Outcome measures
| Measure |
TCM-700C
n=42 Participants
TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
Placebo
n=42 Participants
Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
|
|---|---|---|
|
Immune Cell Normalization
CD4
|
30 participants
|
25 participants
|
|
Immune Cell Normalization
CD8
|
34 participants
|
30 participants
|
|
Immune Cell Normalization
NK cells
|
36 participants
|
31 participants
|
Adverse Events
TCM-700C (Safety Population)
Serious events: 9 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo (Safety Population)
Serious events: 6 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TCM-700C (Safety Population)
n=41 participants at risk
TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C
|
Placebo (Safety Population)
n=42 participants at risk
Placebo with convetional treatment(PegIFN plus RBV) for HCV patients
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Infections and infestations
Urinary infection
|
4.9%
2/41 • Number of events 2 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
Fever/pain
|
4.9%
2/41 • Number of events 2 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • Number of events 2 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
block stools
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
sinusitis
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Ear and labyrinth disorders
hearing impairment
|
2.4%
1/41 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Endocrine disorders
Rhinorhea
|
2.4%
1/41 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Nervous system disorders
neuritic depression
|
2.4%
1/41 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
lose weight
|
2.4%
1/41 • Number of events 1 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
Other adverse events
| Measure |
TCM-700C (Safety Population)
n=41 participants at risk
TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C
|
Placebo (Safety Population)
n=42 participants at risk
Placebo with convetional treatment(PegIFN plus RBV) for HCV patients
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
19.5%
8/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
23.8%
10/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Cardiac disorders
Palpiations
|
7.3%
3/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Ear and labyrinth disorders
Deafness
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Endocrine disorders
Goitre
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Endocrine disorders
Hypothyroidism
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Eye disorders
Conjunctivities
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Eye disorders
Dry Eye
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Eye disorders
Eye pain
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Abdominal distention
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
3/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.2%
5/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
14.3%
6/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Apthous stomatits
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Diarrhea
|
12.2%
5/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
14.3%
6/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
3/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
14.3%
6/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
7.1%
3/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
11.9%
5/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Nausea
|
12.2%
5/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
19.0%
8/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Peptic ulcer
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Gastrointestinal disorders
Reflux esophagitis
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
Asthenia
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
7.1%
3/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
Chills
|
12.2%
5/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
Malaise
|
12.2%
5/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
19.0%
8/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
Pain
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Infections and infestations
Influenza
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
7.1%
3/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
7.1%
3/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Infections and infestations
Urinary tract infection
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
7.1%
3/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
Fatigue
|
22.0%
9/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
14.3%
6/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
Injection site erythema
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
Edema peripheral
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
General disorders
Pyrexia
|
41.5%
17/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
31.0%
13/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
7.1%
3/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Investigations
Hemoglobin decreased
|
24.4%
10/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
21.4%
9/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Investigations
Neutrophil count decreased
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
7.1%
3/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Investigations
Weight decreased
|
7.3%
3/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Investigations
White blood cell count decreased
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.2%
5/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
14.3%
6/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Metabolism and nutrition disorders
Hyperuricaemi
|
2.4%
1/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.6%
6/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
14.3%
6/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.6%
6/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
11.9%
5/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Nervous system disorders
Dizziness
|
26.8%
11/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
19.0%
8/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Nervous system disorders
Headache
|
26.8%
11/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Nervous system disorders
Hypoesthesia
|
2.4%
1/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Nervous system disorders
Tremor
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Psychiatric disorders
Aggression
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Psychiatric disorders
Anxiety
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
9.5%
4/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Psychiatric disorders
Insomnia
|
24.4%
10/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
19.0%
8/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Psychiatric disorders
Mood altered
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Renal and urinary disorders
Dysuria
|
2.4%
1/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Renal and urinary disorders
Urinary incontinency
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.8%
11/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
31.0%
13/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.5%
8/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
23.8%
10/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.3%
3/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
14.3%
6/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
0.00%
0/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.1%
7/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
16.7%
7/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
36.6%
15/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
38.1%
16/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.5%
8/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
7.1%
3/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
4.8%
2/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
9.8%
4/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.9%
2/41 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
2.4%
1/42 • 72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study. one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60