Trial Outcomes & Findings for Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients (NCT NCT00637923)
NCT ID: NCT00637923
Last Updated: 2014-02-10
Results Overview
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
24 weeks after end of treatment
Results posted on
2014-02-10
Participant Flow
This study recruited patients from 13 study centers in the United States, including 2 Veterans Administration hospitals.
Participant milestones
| Measure |
NTZ+PR
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
37
|
|
Overall Study
COMPLETED
|
45
|
18
|
|
Overall Study
NOT COMPLETED
|
30
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients
Baseline characteristics by cohort
| Measure |
NTZ+PR
n=75 Participants
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=37 Participants
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
111 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 7 • n=93 Participants
|
51 years
STANDARD_DEVIATION 8 • n=4 Participants
|
50 years
STANDARD_DEVIATION 7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=93 Participants
|
37 participants
n=4 Participants
|
112 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after end of treatmentHepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
Outcome measures
| Measure |
NTZ+PR
n=75 Participants
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=37 Participants
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
Responders
|
32 participants
|
13 participants
|
|
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
Non-responders
|
43 participants
|
24 participants
|
SECONDARY outcome
Timeframe: At end of treatmentHepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.
Outcome measures
| Measure |
NTZ+PR
n=75 Participants
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=37 Participants
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
End of Treatment Response (HCV RNA Below Lower Limit of Detection)
Responders
|
46 participants
|
18 participants
|
|
End of Treatment Response (HCV RNA Below Lower Limit of Detection)
Non-responders
|
29 participants
|
19 participants
|
SECONDARY outcome
Timeframe: After 12 weeks combination treatmentHepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.
Outcome measures
| Measure |
NTZ+PR
n=75 Participants
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=37 Participants
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Early Virologic Response (HCV RNA Below Lower Limit of Detection)
Responders
|
45 participants
|
18 participants
|
|
Early Virologic Response (HCV RNA Below Lower Limit of Detection)
Non-responders
|
30 participants
|
19 participants
|
SECONDARY outcome
Timeframe: After 4 weeks combination treatmentHepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.
Outcome measures
| Measure |
NTZ+PR
n=75 Participants
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=37 Participants
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
Responders
|
9 participants
|
7 participants
|
|
Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
Non-responders
|
66 participants
|
30 participants
|
SECONDARY outcome
Timeframe: From baseline to week 8Population: This analysis was conducted using only data for patients that completed the baseline through week 8 time points.
This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Outcome measures
| Measure |
NTZ+PR
n=71 Participants
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=35 Participants
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Changes in ALT
Remains Elevated
|
23 participants
|
5 participants
|
|
Changes in ALT
Elevated to Normal
|
29 participants
|
11 participants
|
|
Changes in ALT
Remains Normal
|
16 participants
|
17 participants
|
|
Changes in ALT
Normal to Elevated
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: From baseline to week 16Population: This analysis was conducted using only data for patients that completed the baseline through week 16 time points.
This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up
Outcome measures
| Measure |
NTZ+PR
n=68 Participants
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=31 Participants
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Changes in ALT
Remains Elevated
|
12 participants
|
4 participants
|
|
Changes in ALT
Elevated to Normal
|
38 participants
|
11 participants
|
|
Changes in ALT
Remains Normal
|
17 participants
|
15 participants
|
|
Changes in ALT
Normal to Elevated
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From baseline to end of treatmentPopulation: This analysis was conducted using only data for patients that completed the baseline through end of treatment time points.
This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Outcome measures
| Measure |
NTZ+PR
n=45 Participants
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=18 Participants
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Changes in ALT
Remains Elevated
|
4 participants
|
3 participants
|
|
Changes in ALT
Elevated to Normal
|
28 participants
|
6 participants
|
|
Changes in ALT
Remains Normal
|
13 participants
|
9 participants
|
|
Changes in ALT
Normal to Elevated
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline to end of follow upPopulation: This analysis was conducted using only data for patients that completed the baseline through the end of follow-up time points.
This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Outcome measures
| Measure |
NTZ+PR
n=45 Participants
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=18 Participants
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Changes in ALT
Remains Elevated
|
9 participants
|
2 participants
|
|
Changes in ALT
Elevated to Normal
|
23 participants
|
7 participants
|
|
Changes in ALT
Remains Normal
|
13 participants
|
8 participants
|
|
Changes in ALT
Normal to Elevated
|
0 participants
|
1 participants
|
Adverse Events
NTZ+PR
Serious events: 12 serious events
Other events: 73 other events
Deaths: 0 deaths
Placebo+PR
Serious events: 7 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NTZ+PR
n=75 participants at risk
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=37 participants at risk
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
PAIN ABDO
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
Gastrointestinal disorders
DIARRHEA
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
4.0%
3/75 • Number of events 3 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
10.8%
4/37 • Number of events 4 • 1 year, 10 months
|
|
Eye disorders
RETINAL DIS
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
CARCINOMA LUNG
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Gastrointestinal disorders
GASTROENTERITIS
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIR
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Cardiac disorders
INFARCT MYOCARD
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Renal and urinary disorders
KIDNEY FAIL
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
Metabolism and nutrition disorders
DEHYDRAT
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Gastrointestinal disorders
CONSTIP
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Nervous system disorders
SYNCOPE
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Musculoskeletal and connective tissue disorders
BONE FRACT SPONTAN
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Metabolism and nutrition disorders
HYPOKALEM
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Gastrointestinal disorders
HEM GI
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
|
Vascular disorders
HYPERTENS
|
0.00%
0/75 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
General disorders
FEVER
|
0.00%
0/75 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
EFFUS PLEURAL
|
0.00%
0/75 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
APNEA
|
0.00%
0/75 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
Cardiac disorders
HEART ARREST
|
0.00%
0/75 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
Nervous system disorders
EMOTION LABIL
|
0.00%
0/75 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
Metabolism and nutrition disorders
HYPERKALEM
|
0.00%
0/75 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
General disorders
ASTHENIA
|
1.3%
1/75 • Number of events 1 • 1 year, 10 months
|
0.00%
0/37 • 1 year, 10 months
|
Other adverse events
| Measure |
NTZ+PR
n=75 participants at risk
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
Placebo+PR
n=37 participants at risk
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
48.0%
36/75 • Number of events 36 • 1 year, 10 months
|
21.6%
8/37 • Number of events 8 • 1 year, 10 months
|
|
Gastrointestinal disorders
Nausea
|
42.7%
32/75 • Number of events 32 • 1 year, 10 months
|
27.0%
10/37 • Number of events 10 • 1 year, 10 months
|
|
Gastrointestinal disorders
Anorexia
|
28.0%
21/75 • Number of events 21 • 1 year, 10 months
|
10.8%
4/37 • Number of events 4 • 1 year, 10 months
|
|
Gastrointestinal disorders
Stomatitis Ulcer
|
13.3%
10/75 • Number of events 10 • 1 year, 10 months
|
5.4%
2/37 • Number of events 2 • 1 year, 10 months
|
|
Gastrointestinal disorders
Vomit
|
12.0%
9/75 • Number of events 9 • 1 year, 10 months
|
2.7%
1/37 • Number of events 1 • 1 year, 10 months
|
|
Gastrointestinal disorders
Constip
|
12.0%
9/75 • Number of events 9 • 1 year, 10 months
|
13.5%
5/37 • Number of events 5 • 1 year, 10 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
4/75 • Number of events 4 • 1 year, 10 months
|
16.2%
6/37 • Number of events 6 • 1 year, 10 months
|
|
General disorders
Asthenia
|
69.3%
52/75 • Number of events 52 • 1 year, 10 months
|
67.6%
25/37 • Number of events 25 • 1 year, 10 months
|
|
General disorders
Headache
|
34.7%
26/75 • Number of events 26 • 1 year, 10 months
|
40.5%
15/37 • Number of events 15 • 1 year, 10 months
|
|
General disorders
Pain
|
29.3%
22/75 • Number of events 22 • 1 year, 10 months
|
18.9%
7/37 • Number of events 7 • 1 year, 10 months
|
|
General disorders
Fever
|
20.0%
15/75 • Number of events 15 • 1 year, 10 months
|
16.2%
6/37 • Number of events 6 • 1 year, 10 months
|
|
Gastrointestinal disorders
Pain Abdo
|
16.0%
12/75 • Number of events 12 • 1 year, 10 months
|
16.2%
6/37 • Number of events 6 • 1 year, 10 months
|
|
General disorders
Chills
|
14.7%
11/75 • Number of events 11 • 1 year, 10 months
|
10.8%
4/37 • Number of events 4 • 1 year, 10 months
|
|
General disorders
Inject site react
|
12.0%
9/75 • Number of events 9 • 1 year, 10 months
|
5.4%
2/37 • Number of events 2 • 1 year, 10 months
|
|
General disorders
Flu Synd
|
8.0%
6/75 • Number of events 6 • 1 year, 10 months
|
10.8%
4/37 • Number of events 4 • 1 year, 10 months
|
|
Nervous system disorders
Insomnia
|
36.0%
27/75 • Number of events 27 • 1 year, 10 months
|
27.0%
10/37 • Number of events 10 • 1 year, 10 months
|
|
Nervous system disorders
Nervousness
|
32.0%
24/75 • Number of events 24 • 1 year, 10 months
|
16.2%
6/37 • Number of events 6 • 1 year, 10 months
|
|
Nervous system disorders
Depression
|
29.3%
22/75 • Number of events 22 • 1 year, 10 months
|
24.3%
9/37 • Number of events 9 • 1 year, 10 months
|
|
Nervous system disorders
Thinking Abnorm
|
21.3%
16/75 • Number of events 16 • 1 year, 10 months
|
16.2%
6/37 • Number of events 6 • 1 year, 10 months
|
|
Nervous system disorders
Dizziness
|
16.0%
12/75 • Number of events 12 • 1 year, 10 months
|
16.2%
6/37 • Number of events 6 • 1 year, 10 months
|
|
Nervous system disorders
Emotion labil
|
13.3%
10/75 • Number of events 10 • 1 year, 10 months
|
18.9%
7/37 • Number of events 7 • 1 year, 10 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
49.3%
37/75 • Number of events 37 • 1 year, 10 months
|
29.7%
11/37 • Number of events 11 • 1 year, 10 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
32.0%
24/75 • Number of events 24 • 1 year, 10 months
|
21.6%
8/37 • Number of events 8 • 1 year, 10 months
|
|
Skin and subcutaneous tissue disorders
Skin dry
|
28.0%
21/75 • Number of events 21 • 1 year, 10 months
|
16.2%
6/37 • Number of events 6 • 1 year, 10 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.3%
19/75 • Number of events 19 • 1 year, 10 months
|
8.1%
3/37 • Number of events 3 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.3%
31/75 • Number of events 31 • 1 year, 10 months
|
32.4%
12/37 • Number of events 12 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
17.3%
13/75 • Number of events 13 • 1 year, 10 months
|
21.6%
8/37 • Number of events 8 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough inc
|
16.0%
12/75 • Number of events 12 • 1 year, 10 months
|
10.8%
4/37 • Number of events 4 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
14.7%
11/75 • Number of events 11 • 1 year, 10 months
|
8.1%
3/37 • Number of events 3 • 1 year, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.7%
2/75 • Number of events 2 • 1 year, 10 months
|
13.5%
5/37 • Number of events 5 • 1 year, 10 months
|
|
Renal and urinary disorders
Urin Abnorm
|
42.7%
32/75 • Number of events 32 • 1 year, 10 months
|
5.4%
2/37 • Number of events 2 • 1 year, 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
30/75 • Number of events 30 • 1 year, 10 months
|
29.7%
11/37 • Number of events 11 • 1 year, 10 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.3%
16/75 • Number of events 16 • 1 year, 10 months
|
27.0%
10/37 • Number of events 10 • 1 year, 10 months
|
|
Metabolism and nutrition disorders
Weight dec
|
16.0%
12/75 • Number of events 12 • 1 year, 10 months
|
16.2%
6/37 • Number of events 6 • 1 year, 10 months
|
|
Metabolism and nutrition disorders
Hypercholesterem
|
0.00%
0/75 • 1 year, 10 months
|
10.8%
4/37 • Number of events 4 • 1 year, 10 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.7%
14/75 • Number of events 14 • 1 year, 10 months
|
8.1%
3/37 • Number of events 3 • 1 year, 10 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.7%
11/75 • Number of events 11 • 1 year, 10 months
|
24.3%
9/37 • Number of events 9 • 1 year, 10 months
|
|
Vascular disorders
Hypertens
|
0.00%
0/75 • 1 year, 10 months
|
10.8%
4/37 • Number of events 4 • 1 year, 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Presentation and/or publication is encouraged provided the Sponsor is notified in advance and given the opportunity to review the manuscript or abstract 30 days prior to its submission for presentation at a scientific meeting or for publication in a scientific journal. The investigators will have complete autonomy regarding the content and wording including the decision of whether or not to publish.
- Publication restrictions are in place
Restriction type: OTHER