Trial Outcomes & Findings for Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523) (NCT NCT00423670)
NCT ID: NCT00423670
Last Updated: 2017-04-05
Results Overview
Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL). A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
765 participants
Primary outcome timeframe
From follow-up week (FW) 24 up to end of follow-up (EOF)
Results posted on
2017-04-05
Participant Flow
765 participants were screened in the study, 598 were randomized of which 3 participants were not treated (Arm 1-7). Participants were assigned to Part I (with standard dosing for ribavirin) or Part II (to explore low-dose ribavirin). All participants that completed or discontinued treatment were scheduled to enter follow-up phase per protocol.
Participants in Arm 1 (Part I) who had detectable Hepatitis C Virus-ribonucleic acid (HCV-RNA) at Treatment Week (TW) 24 were offered boceprevir in addition to PegIntron and ribavirin for an additional 24 weeks of treatment, and switched to a new arm, Arm 8.
Participant milestones
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg, once weekly \[QW\]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day \[TID\]) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
104
|
107
|
103
|
103
|
103
|
16
|
59
|
36
|
|
Treatment Period
COMPLETED
|
52
|
77
|
76
|
63
|
76
|
8
|
28
|
15
|
|
Treatment Period
NOT COMPLETED
|
52
|
30
|
27
|
40
|
27
|
8
|
31
|
21
|
|
Follow-up Period
STARTED
|
97
|
100
|
96
|
96
|
91
|
14
|
50
|
35
|
|
Follow-up Period
COMPLETED
|
94
|
84
|
85
|
91
|
89
|
14
|
41
|
32
|
|
Follow-up Period
NOT COMPLETED
|
3
|
16
|
11
|
5
|
2
|
0
|
9
|
3
|
Reasons for withdrawal
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg, once weekly \[QW\]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day \[TID\]) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Period
Switched to Arm 8 at TW 24
|
36
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Adverse Event
|
8
|
12
|
15
|
20
|
9
|
4
|
7
|
2
|
|
Treatment Period
Protocol-defined clinical event
|
0
|
7
|
4
|
12
|
5
|
4
|
16
|
15
|
|
Treatment Period
Lost to Follow-up
|
2
|
1
|
3
|
1
|
6
|
0
|
3
|
1
|
|
Treatment Period
Subject withdrew (not treatment related)
|
3
|
9
|
4
|
4
|
5
|
0
|
3
|
0
|
|
Treatment Period
Investigator decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Non-compliance with protocol
|
3
|
1
|
1
|
3
|
2
|
0
|
2
|
2
|
|
Follow-up Period
Lost to Follow-up
|
0
|
12
|
8
|
3
|
1
|
0
|
5
|
0
|
|
Follow-up Period
Subject withdrew (not treatment related)
|
1
|
4
|
2
|
1
|
1
|
0
|
1
|
1
|
|
Follow-up Period
Non-compliance with protocol
|
2
|
0
|
1
|
1
|
0
|
0
|
3
|
2
|
Baseline Characteristics
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
Baseline characteristics by cohort
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
n=104 Participants
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
n=107 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
n=103 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
n=103 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
n=103 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
n=16 Participants
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
n=59 Participants
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Total
n=595 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
47.6 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
50.3 years
STANDARD_DEVIATION 8.5 • n=8 Participants
|
48.7 years
STANDARD_DEVIATION 5.8 • n=8 Participants
|
47.5 years
STANDARD_DEVIATION 7.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
240 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
355 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From follow-up week (FW) 24 up to end of follow-up (EOF)Population: Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).
Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL). A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR.
Outcome measures
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
n=104 Participants
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
n=107 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
n=103 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
n=103 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
n=103 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
n=16 Participants
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
n=59 Participants
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Sustained Virologic Response (SVR)
|
39 Participants
|
58 Participants
|
58 Participants
|
69 Participants
|
77 Participants
|
8 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From FW 24 up to EOFPopulation: Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).
Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Outcome measures
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
n=206 Participants
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
n=210 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin
|
135 Participants
|
127 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From FW 24 up to EOFPopulation: Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).
Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Outcome measures
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
n=206 Participants
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
n=210 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With SVR Based on Duration of Boceprevir Treatment
|
146 Participants
|
116 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At FW 12Population: Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).
Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Outcome measures
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
n=104 Participants
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
n=107 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
n=103 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
n=103 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
n=103 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
n=16 Participants
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
n=59 Participants
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Negative for HCV-RNA at FW 12
HCV-RNA negative
|
39 Participants
|
60 Participants
|
59 Participants
|
69 Participants
|
76 Participants
|
8 Participants
|
21 Participants
|
|
Number of Participants Negative for HCV-RNA at FW 12
Missing HCV-RNA at FW 12
|
42 Participants
|
13 Participants
|
11 Participants
|
12 Participants
|
14 Participants
|
2 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 72 weeks post randomizationParticipants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Outcome measures
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
n=104 Participants
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
n=107 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
n=103 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
n=103 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
n=103 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
n=16 Participants
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
n=59 Participants
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization
HCV-RNA negative
|
38 Participants
|
53 Participants
|
56 Participants
|
67 Participants
|
76 Participants
|
8 Participants
|
20 Participants
|
|
Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization
Missing HCV-RNA at 72 weeks post randomization
|
45 Participants
|
25 Participants
|
18 Participants
|
17 Participants
|
20 Participants
|
6 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: At TW 12, and at FW 24 up to EOFPopulation: Participants with an early virologic response (EVR).
Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. if he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Outcome measures
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
n=37 Participants
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
n=85 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
n=85 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
n=81 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
n=85 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
n=11 Participants
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
n=35 Participants
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With an Early Virologic Response (EVR) That Achieved SVR
|
32 Participants
|
58 Participants
|
58 Participants
|
68 Participants
|
77 Participants
|
8 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: At FW 12 and FW 24 up to EOFPopulation: Participants with undetectable HCV-RNA at FW 12.
Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. if he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Outcome measures
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
n=39 Participants
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
n=60 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
n=59 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
n=69 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
n=76 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
n=8 Participants
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
n=21 Participants
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR
HCV-RNA negative at EOF
|
39 Participants
|
58 Participants
|
58 Participants
|
69 Participants
|
76 Participants
|
8 Participants
|
20 Participants
|
|
Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR
HCV-RNA positive at EOF
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR
Missing HCV-RNA at EOF
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At FW 24 up to EOF and at 72 weeks post randomizationPopulation: Participants who achieved SVR.
Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. if he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL.
Outcome measures
| Measure |
Arm 1. PEG +RBV for 48 Wks (Part I)
n=39 Participants
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
|
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
n=58 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
n=58 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
n=69 Participants
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
n=77 Participants
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
n=8 Participants
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
n=21 Participants
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR
HCV-RNA negative at 72 weeks post randomization
|
38 Participants
|
53 Participants
|
56 Participants
|
67 Participants
|
76 Participants
|
8 Participants
|
20 Participants
|
|
Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR
HCV-RNA positive at FW 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR
Missing HCV-RNA at 72 weeks post randomization
|
1 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
PEG +RBV for 48 Wks (Part I)
Serious events: 8 serious events
Other events: 102 other events
Deaths: 0 deaths
PEG + RBV + BOC for 28 Wks (Part I)
Serious events: 10 serious events
Other events: 106 other events
Deaths: 0 deaths
PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
Serious events: 8 serious events
Other events: 102 other events
Deaths: 0 deaths
PEG +RBV + BOC for 48 Wks (Part I)
Serious events: 10 serious events
Other events: 103 other events
Deaths: 0 deaths
PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)
Serious events: 6 serious events
Other events: 102 other events
Deaths: 0 deaths
PEG + RBV + BOC for 48 Wks (Part II)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
PEG +Low-dose RBV + BOC for 48 Wks (Part II)
Serious events: 3 serious events
Other events: 59 other events
Deaths: 0 deaths
PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG +RBV for 48 Wks (Part I)
n=104 participants at risk
Arm 1. PegIntron (1.5 μg/kg, once weekly \[QW\]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day \[TID\]) for 24 additional weeks. Total treatment duration was up to 54 weeks.
Adverse events for 36 participants after they crossed over to Arm 8 are not included.
|
PEG + RBV + BOC for 28 Wks (Part I)
n=107 participants at risk
Arm 2. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
n=103 participants at risk
Arm 3. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
PEG +RBV + BOC for 48 Wks (Part I)
n=103 participants at risk
Arm 4. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)
n=103 participants at risk
Arm 5. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
PEG + RBV + BOC for 48 Wks (Part II)
n=16 participants at risk
Arm 6. PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
PEG +Low-dose RBV + BOC for 48 Wks (Part II)
n=59 participants at risk
Arm 7. PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
n=36 participants at risk
Arm 8. Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/104
|
1.9%
2/107 • Number of events 2
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Ear and labyrinth disorders
DEAFNESS UNILATERAL
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Eye disorders
DIPLOPIA
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Eye disorders
RETINAL ISCHAEMIA
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Eye disorders
RETINOPATHY
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Eye disorders
SCOTOMA
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/104
|
1.9%
2/107 • Number of events 2
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
1.9%
2/103 • Number of events 7
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
PERIODONTAL DISEASE
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
PERITONEAL HAEMORRHAGE
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
2.8%
1/36 • Number of events 1
|
|
General disorders
ASTHENIA
|
0.00%
0/104
|
1.9%
2/107 • Number of events 2
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
General disorders
CHEST PAIN
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
General disorders
FATIGUE
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
General disorders
LOCAL SWELLING
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
General disorders
PYREXIA
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
CORNEAL INFECTION
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
VULVAL ABSCESS
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
DRUG TOXICITY
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Investigations
BLOOD AMYLASE INCREASED
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 2
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PARATHYROID TUMOUR BENIGN
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Nervous system disorders
CERVICAL CORD COMPRESSION
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Nervous system disorders
IIIRD NERVE PARALYSIS
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
AGGRESSION
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
ALCOHOLISM
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/104
|
0.93%
1/107 • Number of events 2
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
DEPENDENCE
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
HOMICIDAL IDEATION
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
PARANOIA
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.96%
1/104 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Surgical and medical procedures
UMBILICAL HERNIA REPAIR
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
Other adverse events
| Measure |
PEG +RBV for 48 Wks (Part I)
n=104 participants at risk
Arm 1. PegIntron (1.5 μg/kg, once weekly \[QW\]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day \[TID\]) for 24 additional weeks. Total treatment duration was up to 54 weeks.
Adverse events for 36 participants after they crossed over to Arm 8 are not included.
|
PEG + RBV + BOC for 28 Wks (Part I)
n=107 participants at risk
Arm 2. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
|
PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
n=103 participants at risk
Arm 3. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
|
PEG +RBV + BOC for 48 Wks (Part I)
n=103 participants at risk
Arm 4. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
|
PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)
n=103 participants at risk
Arm 5. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
|
PEG + RBV + BOC for 48 Wks (Part II)
n=16 participants at risk
Arm 6. PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
PEG +Low-dose RBV + BOC for 48 Wks (Part II)
n=59 participants at risk
Arm 7. PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
|
PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
n=36 participants at risk
Arm 8. Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
33.7%
35/104 • Number of events 55
|
55.1%
59/107 • Number of events 96
|
53.4%
55/103 • Number of events 80
|
52.4%
54/103 • Number of events 79
|
56.3%
58/103 • Number of events 88
|
62.5%
10/16 • Number of events 22
|
23.7%
14/59 • Number of events 39
|
36.1%
13/36 • Number of events 13
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
5.8%
6/104 • Number of events 15
|
6.5%
7/107 • Number of events 37
|
4.9%
5/103 • Number of events 12
|
4.9%
5/103 • Number of events 9
|
7.8%
8/103 • Number of events 12
|
6.2%
1/16 • Number of events 7
|
15.3%
9/59 • Number of events 58
|
2.8%
1/36 • Number of events 2
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/104
|
1.9%
2/107 • Number of events 2
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
11.5%
12/104 • Number of events 32
|
21.5%
23/107 • Number of events 82
|
15.5%
16/103 • Number of events 30
|
25.2%
26/103 • Number of events 50
|
30.1%
31/103 • Number of events 71
|
12.5%
2/16 • Number of events 11
|
32.2%
19/59 • Number of events 88
|
22.2%
8/36 • Number of events 9
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/104
|
4.7%
5/107 • Number of events 7
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
5.8%
6/103 • Number of events 9
|
6.2%
1/16 • Number of events 1
|
8.5%
5/59 • Number of events 26
|
8.3%
3/36 • Number of events 3
|
|
Cardiac disorders
PALPITATIONS
|
1.9%
2/104 • Number of events 3
|
0.93%
1/107 • Number of events 1
|
1.9%
2/103 • Number of events 2
|
2.9%
3/103 • Number of events 3
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Ear and labyrinth disorders
TINNITUS
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
2.9%
3/103 • Number of events 3
|
6.8%
7/103 • Number of events 7
|
2.9%
3/103 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Endocrine disorders
HYPOTHYROIDISM
|
5.8%
6/104 • Number of events 6
|
1.9%
2/107 • Number of events 2
|
2.9%
3/103 • Number of events 3
|
0.97%
1/103 • Number of events 1
|
4.9%
5/103 • Number of events 9
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Eye disorders
CONJUNCTIVAL DISCOLOURATION
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Eye disorders
CONJUNCTIVITIS
|
0.96%
1/104 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
2.9%
3/103 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Eye disorders
DRY EYE
|
3.8%
4/104 • Number of events 4
|
0.93%
1/107 • Number of events 1
|
2.9%
3/103 • Number of events 4
|
5.8%
6/103 • Number of events 6
|
3.9%
4/103 • Number of events 4
|
12.5%
2/16 • Number of events 2
|
8.5%
5/59 • Number of events 5
|
0.00%
0/36
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Eye disorders
RETINOPATHY
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Eye disorders
VISION BLURRED
|
6.7%
7/104 • Number of events 7
|
5.6%
6/107 • Number of events 6
|
1.9%
2/103 • Number of events 2
|
7.8%
8/103 • Number of events 8
|
6.8%
7/103 • Number of events 7
|
12.5%
2/16 • Number of events 2
|
5.1%
3/59 • Number of events 3
|
0.00%
0/36
|
|
Eye disorders
VISUAL IMPAIRMENT
|
1.9%
2/104 • Number of events 2
|
0.93%
1/107 • Number of events 1
|
4.9%
5/103 • Number of events 5
|
6.8%
7/103 • Number of events 7
|
2.9%
3/103 • Number of events 3
|
0.00%
0/16
|
3.4%
2/59 • Number of events 2
|
0.00%
0/36
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
1.9%
2/104 • Number of events 2
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.96%
1/104 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
2.9%
3/103 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.7%
9/104 • Number of events 12
|
3.7%
4/107 • Number of events 4
|
5.8%
6/103 • Number of events 6
|
9.7%
10/103 • Number of events 10
|
5.8%
6/103 • Number of events 7
|
6.2%
1/16 • Number of events 1
|
3.4%
2/59 • Number of events 3
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.8%
5/104 • Number of events 5
|
6.5%
7/107 • Number of events 8
|
4.9%
5/103 • Number of events 7
|
8.7%
9/103 • Number of events 9
|
11.7%
12/103 • Number of events 15
|
12.5%
2/16 • Number of events 2
|
8.5%
5/59 • Number of events 6
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
1.9%
2/104 • Number of events 2
|
1.9%
2/107 • Number of events 3
|
2.9%
3/103 • Number of events 4
|
3.9%
4/103 • Number of events 4
|
3.9%
4/103 • Number of events 4
|
12.5%
2/16 • Number of events 2
|
5.1%
3/59 • Number of events 3
|
0.00%
0/36
|
|
Gastrointestinal disorders
CHEILITIS
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
1.9%
2/103 • Number of events 4
|
1.9%
2/103 • Number of events 2
|
6.2%
1/16 • Number of events 2
|
0.00%
0/59
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.6%
11/104 • Number of events 13
|
4.7%
5/107 • Number of events 5
|
13.6%
14/103 • Number of events 17
|
8.7%
9/103 • Number of events 10
|
8.7%
9/103 • Number of events 10
|
6.2%
1/16 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHOEA
|
22.1%
23/104 • Number of events 31
|
26.2%
28/107 • Number of events 40
|
26.2%
27/103 • Number of events 29
|
24.3%
25/103 • Number of events 30
|
28.2%
29/103 • Number of events 36
|
31.2%
5/16 • Number of events 5
|
23.7%
14/59 • Number of events 18
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
DRY MOUTH
|
4.8%
5/104 • Number of events 5
|
13.1%
14/107 • Number of events 15
|
7.8%
8/103 • Number of events 8
|
11.7%
12/103 • Number of events 15
|
9.7%
10/103 • Number of events 10
|
12.5%
2/16 • Number of events 2
|
8.5%
5/59 • Number of events 7
|
5.6%
2/36 • Number of events 3
|
|
Gastrointestinal disorders
DYSPEPSIA
|
7.7%
8/104 • Number of events 9
|
5.6%
6/107 • Number of events 8
|
7.8%
8/103 • Number of events 8
|
8.7%
9/103 • Number of events 10
|
7.8%
8/103 • Number of events 8
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
4.8%
5/104 • Number of events 5
|
10.3%
11/107 • Number of events 12
|
2.9%
3/103 • Number of events 4
|
7.8%
8/103 • Number of events 9
|
9.7%
10/103 • Number of events 11
|
6.2%
1/16 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/104
|
0.00%
0/107
|
1.9%
2/103 • Number of events 2
|
0.00%
0/103
|
2.9%
3/103 • Number of events 4
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
6.7%
7/104 • Number of events 7
|
4.7%
5/107 • Number of events 6
|
1.9%
2/103 • Number of events 2
|
2.9%
3/103 • Number of events 3
|
0.97%
1/103 • Number of events 1
|
18.8%
3/16 • Number of events 3
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
NAUSEA
|
43.3%
45/104 • Number of events 52
|
38.3%
41/107 • Number of events 50
|
40.8%
42/103 • Number of events 53
|
53.4%
55/103 • Number of events 80
|
46.6%
48/103 • Number of events 87
|
62.5%
10/16 • Number of events 13
|
59.3%
35/59 • Number of events 40
|
11.1%
4/36 • Number of events 4
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
3.9%
4/103 • Number of events 4
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
2.9%
3/104 • Number of events 3
|
1.9%
2/107 • Number of events 2
|
1.9%
2/103 • Number of events 2
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
0.00%
0/16
|
0.00%
0/59
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
SALIVARY HYPERSECRETION
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
STOMACH DISCOMFORT
|
2.9%
3/104 • Number of events 4
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
2.9%
3/103 • Number of events 3
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
0.00%
0/36
|
|
Gastrointestinal disorders
STOMATITIS
|
1.9%
2/104 • Number of events 2
|
6.5%
7/107 • Number of events 8
|
4.9%
5/103 • Number of events 5
|
4.9%
5/103 • Number of events 7
|
3.9%
4/103 • Number of events 5
|
0.00%
0/16
|
0.00%
0/59
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.9%
2/104 • Number of events 2
|
2.8%
3/107 • Number of events 3
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Gastrointestinal disorders
VOMITING
|
4.8%
5/104 • Number of events 7
|
22.4%
24/107 • Number of events 27
|
14.6%
15/103 • Number of events 21
|
24.3%
25/103 • Number of events 28
|
16.5%
17/103 • Number of events 23
|
43.8%
7/16 • Number of events 8
|
18.6%
11/59 • Number of events 14
|
5.6%
2/36 • Number of events 2
|
|
General disorders
ASTHENIA
|
13.5%
14/104 • Number of events 18
|
8.4%
9/107 • Number of events 12
|
8.7%
9/103 • Number of events 18
|
19.4%
20/103 • Number of events 27
|
14.6%
15/103 • Number of events 26
|
6.2%
1/16 • Number of events 2
|
5.1%
3/59 • Number of events 3
|
8.3%
3/36 • Number of events 4
|
|
General disorders
CHEST DISCOMFORT
|
2.9%
3/104 • Number of events 3
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
1.9%
2/103 • Number of events 2
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
3.4%
2/59 • Number of events 3
|
0.00%
0/36
|
|
General disorders
CHILLS
|
33.7%
35/104 • Number of events 38
|
29.0%
31/107 • Number of events 39
|
30.1%
31/103 • Number of events 34
|
32.0%
33/103 • Number of events 37
|
34.0%
35/103 • Number of events 39
|
31.2%
5/16 • Number of events 6
|
44.1%
26/59 • Number of events 29
|
0.00%
0/36
|
|
General disorders
FATIGUE
|
54.8%
57/104 • Number of events 62
|
60.7%
65/107 • Number of events 78
|
68.0%
70/103 • Number of events 80
|
49.5%
51/103 • Number of events 69
|
70.9%
73/103 • Number of events 95
|
68.8%
11/16 • Number of events 14
|
67.8%
40/59 • Number of events 55
|
13.9%
5/36 • Number of events 5
|
|
General disorders
IMPAIRED HEALING
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
24.0%
25/104 • Number of events 37
|
22.4%
24/107 • Number of events 26
|
20.4%
21/103 • Number of events 22
|
18.4%
19/103 • Number of events 20
|
14.6%
15/103 • Number of events 27
|
37.5%
6/16 • Number of events 6
|
18.6%
11/59 • Number of events 11
|
0.00%
0/36
|
|
General disorders
INJECTION SITE ERYTHEMA
|
12.5%
13/104 • Number of events 13
|
8.4%
9/107 • Number of events 9
|
13.6%
14/103 • Number of events 14
|
6.8%
7/103 • Number of events 7
|
12.6%
13/103 • Number of events 13
|
6.2%
1/16 • Number of events 1
|
6.8%
4/59 • Number of events 4
|
2.8%
1/36 • Number of events 1
|
|
General disorders
INJECTION SITE RASH
|
5.8%
6/104 • Number of events 6
|
2.8%
3/107 • Number of events 3
|
0.00%
0/103
|
2.9%
3/103 • Number of events 3
|
5.8%
6/103 • Number of events 6
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
General disorders
INJECTION SITE REACTION
|
9.6%
10/104 • Number of events 12
|
8.4%
9/107 • Number of events 9
|
4.9%
5/103 • Number of events 5
|
8.7%
9/103 • Number of events 9
|
10.7%
11/103 • Number of events 11
|
25.0%
4/16 • Number of events 4
|
35.6%
21/59 • Number of events 21
|
2.8%
1/36 • Number of events 1
|
|
General disorders
IRRITABILITY
|
22.1%
23/104 • Number of events 23
|
23.4%
25/107 • Number of events 26
|
23.3%
24/103 • Number of events 27
|
14.6%
15/103 • Number of events 21
|
26.2%
27/103 • Number of events 32
|
18.8%
3/16 • Number of events 3
|
15.3%
9/59 • Number of events 11
|
0.00%
0/36
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.96%
1/104 • Number of events 1
|
1.9%
2/107 • Number of events 2
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
0.97%
1/103 • Number of events 1
|
12.5%
2/16 • Number of events 3
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
General disorders
PAIN
|
7.7%
8/104 • Number of events 8
|
10.3%
11/107 • Number of events 11
|
8.7%
9/103 • Number of events 10
|
10.7%
11/103 • Number of events 12
|
4.9%
5/103 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
18.6%
11/59 • Number of events 12
|
0.00%
0/36
|
|
General disorders
PYREXIA
|
33.7%
35/104 • Number of events 55
|
25.2%
27/107 • Number of events 35
|
26.2%
27/103 • Number of events 34
|
38.8%
40/103 • Number of events 51
|
34.0%
35/103 • Number of events 53
|
43.8%
7/16 • Number of events 10
|
44.1%
26/59 • Number of events 31
|
0.00%
0/36
|
|
General disorders
TEMPERATURE INTOLERANCE
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 2
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Infections and infestations
BRONCHITIS
|
2.9%
3/104 • Number of events 3
|
3.7%
4/107 • Number of events 6
|
0.97%
1/103 • Number of events 1
|
1.9%
2/103 • Number of events 2
|
0.97%
1/103 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Infections and infestations
EAR INFECTION
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 3
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
EYE INFECTION
|
0.96%
1/104 • Number of events 2
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
INFLUENZA
|
0.96%
1/104 • Number of events 1
|
2.8%
3/107 • Number of events 4
|
0.00%
0/103
|
2.9%
3/103 • Number of events 4
|
2.9%
3/103 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Infections and infestations
LARYNGITIS
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.96%
1/104 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
5.1%
3/59 • Number of events 5
|
0.00%
0/36
|
|
Infections and infestations
PHARYNGITIS
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
1.9%
2/103 • Number of events 2
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 2
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
RECTAL ABSCESS
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
SINUSITIS
|
2.9%
3/104 • Number of events 3
|
2.8%
3/107 • Number of events 4
|
2.9%
3/103 • Number of events 3
|
4.9%
5/103 • Number of events 7
|
4.9%
5/103 • Number of events 5
|
12.5%
2/16 • Number of events 3
|
1.7%
1/59 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
TINEA VERSICOLOUR
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.9%
3/104 • Number of events 3
|
6.5%
7/107 • Number of events 7
|
0.97%
1/103 • Number of events 1
|
3.9%
4/103 • Number of events 4
|
6.8%
7/103 • Number of events 8
|
6.2%
1/16 • Number of events 1
|
10.2%
6/59 • Number of events 7
|
0.00%
0/36
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.9%
3/104 • Number of events 4
|
2.8%
3/107 • Number of events 3
|
2.9%
3/103 • Number of events 3
|
1.9%
2/103 • Number of events 2
|
0.97%
1/103 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
0.00%
0/36
|
|
Investigations
BLOOD URIC ACID INCREASED
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/16
|
5.1%
3/59 • Number of events 5
|
0.00%
0/36
|
|
Investigations
HEART RATE INCREASED
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Investigations
WEIGHT DECREASED
|
8.7%
9/104 • Number of events 9
|
5.6%
6/107 • Number of events 6
|
7.8%
8/103 • Number of events 8
|
5.8%
6/103 • Number of events 8
|
8.7%
9/103 • Number of events 10
|
12.5%
2/16 • Number of events 2
|
13.6%
8/59 • Number of events 8
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
ANOREXIA
|
9.6%
10/104 • Number of events 11
|
9.3%
10/107 • Number of events 10
|
7.8%
8/103 • Number of events 8
|
12.6%
13/103 • Number of events 18
|
10.7%
11/103 • Number of events 15
|
12.5%
2/16 • Number of events 2
|
6.8%
4/59 • Number of events 5
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
11.5%
12/104 • Number of events 13
|
6.5%
7/107 • Number of events 7
|
13.6%
14/103 • Number of events 15
|
15.5%
16/103 • Number of events 18
|
11.7%
12/103 • Number of events 12
|
37.5%
6/16 • Number of events 6
|
27.1%
16/59 • Number of events 17
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERAMYLASAEMIA
|
0.96%
1/104 • Number of events 2
|
2.8%
3/107 • Number of events 4
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 2
|
0.00%
0/16
|
5.1%
3/59 • Number of events 3
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
2.9%
3/103 • Number of events 3
|
0.97%
1/103 • Number of events 1
|
2.9%
3/103 • Number of events 3
|
0.00%
0/16
|
5.1%
3/59 • Number of events 3
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
2.9%
3/104 • Number of events 3
|
0.93%
1/107 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
1.9%
2/103 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
20.2%
21/104 • Number of events 24
|
13.1%
14/107 • Number of events 20
|
21.4%
22/103 • Number of events 26
|
20.4%
21/103 • Number of events 25
|
18.4%
19/103 • Number of events 21
|
31.2%
5/16 • Number of events 7
|
18.6%
11/59 • Number of events 13
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.8%
5/104 • Number of events 5
|
4.7%
5/107 • Number of events 5
|
6.8%
7/103 • Number of events 7
|
9.7%
10/103 • Number of events 13
|
8.7%
9/103 • Number of events 11
|
18.8%
3/16 • Number of events 3
|
8.5%
5/59 • Number of events 5
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
4.8%
5/104 • Number of events 7
|
3.7%
4/107 • Number of events 4
|
3.9%
4/103 • Number of events 4
|
5.8%
6/103 • Number of events 6
|
0.97%
1/103 • Number of events 1
|
0.00%
0/16
|
5.1%
3/59 • Number of events 3
|
5.6%
2/36 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
0.96%
1/104 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
3.8%
4/104 • Number of events 4
|
3.7%
4/107 • Number of events 5
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 2
|
0.00%
0/59
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
4.8%
5/104 • Number of events 6
|
3.7%
4/107 • Number of events 5
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
16.3%
17/104 • Number of events 17
|
29.0%
31/107 • Number of events 34
|
19.4%
20/103 • Number of events 20
|
20.4%
21/103 • Number of events 30
|
26.2%
27/103 • Number of events 33
|
25.0%
4/16 • Number of events 5
|
20.3%
12/59 • Number of events 15
|
5.6%
2/36 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.8%
4/104 • Number of events 5
|
3.7%
4/107 • Number of events 4
|
0.00%
0/103
|
5.8%
6/103 • Number of events 7
|
3.9%
4/103 • Number of events 5
|
0.00%
0/16
|
3.4%
2/59 • Number of events 2
|
0.00%
0/36
|
|
Nervous system disorders
AMNESIA
|
0.96%
1/104 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
1.9%
2/103 • Number of events 3
|
4.9%
5/103 • Number of events 6
|
0.97%
1/103 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
3.8%
4/104 • Number of events 5
|
6.5%
7/107 • Number of events 7
|
8.7%
9/103 • Number of events 9
|
6.8%
7/103 • Number of events 8
|
9.7%
10/103 • Number of events 11
|
0.00%
0/16
|
5.1%
3/59 • Number of events 4
|
0.00%
0/36
|
|
Nervous system disorders
DIZZINESS
|
15.4%
16/104 • Number of events 18
|
17.8%
19/107 • Number of events 23
|
15.5%
16/103 • Number of events 18
|
20.4%
21/103 • Number of events 21
|
13.6%
14/103 • Number of events 18
|
43.8%
7/16 • Number of events 8
|
18.6%
11/59 • Number of events 16
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
DYSGEUSIA
|
8.7%
9/104 • Number of events 10
|
21.5%
23/107 • Number of events 25
|
26.2%
27/103 • Number of events 28
|
32.0%
33/103 • Number of events 38
|
27.2%
28/103 • Number of events 31
|
43.8%
7/16 • Number of events 9
|
30.5%
18/59 • Number of events 20
|
19.4%
7/36 • Number of events 7
|
|
Nervous system disorders
HEADACHE
|
43.3%
45/104 • Number of events 60
|
47.7%
51/107 • Number of events 66
|
39.8%
41/103 • Number of events 46
|
42.7%
44/103 • Number of events 52
|
52.4%
54/103 • Number of events 67
|
81.2%
13/16 • Number of events 13
|
49.2%
29/59 • Number of events 35
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
2.9%
3/104 • Number of events 3
|
1.9%
2/107 • Number of events 2
|
1.9%
2/103 • Number of events 2
|
2.9%
3/103 • Number of events 3
|
1.9%
2/103 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
8.5%
5/59 • Number of events 5
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
MIGRAINE
|
1.9%
2/104 • Number of events 3
|
0.93%
1/107 • Number of events 1
|
1.9%
2/103 • Number of events 2
|
4.9%
5/103 • Number of events 5
|
2.9%
3/103 • Number of events 3
|
25.0%
4/16 • Number of events 6
|
1.7%
1/59 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
PARAESTHESIA
|
2.9%
3/104 • Number of events 4
|
4.7%
5/107 • Number of events 6
|
3.9%
4/103 • Number of events 4
|
5.8%
6/103 • Number of events 6
|
1.9%
2/103 • Number of events 2
|
6.2%
1/16 • Number of events 2
|
5.1%
3/59 • Number of events 3
|
0.00%
0/36
|
|
Nervous system disorders
SCIATICA
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 2
|
0.00%
0/59
|
0.00%
0/36
|
|
Nervous system disorders
SOMNOLENCE
|
0.96%
1/104 • Number of events 1
|
0.00%
0/107
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Nervous system disorders
TREMOR
|
2.9%
3/104 • Number of events 3
|
2.8%
3/107 • Number of events 3
|
0.97%
1/103 • Number of events 1
|
2.9%
3/103 • Number of events 3
|
0.97%
1/103 • Number of events 1
|
12.5%
2/16 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
0.00%
0/36
|
|
Nervous system disorders
TRIGEMINAL NEURALGIA
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
ANXIETY
|
17.3%
18/104 • Number of events 21
|
15.0%
16/107 • Number of events 19
|
8.7%
9/103 • Number of events 10
|
14.6%
15/103 • Number of events 17
|
16.5%
17/103 • Number of events 20
|
6.2%
1/16 • Number of events 1
|
13.6%
8/59 • Number of events 11
|
0.00%
0/36
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
1.9%
2/103 • Number of events 2
|
0.00%
0/103
|
2.9%
3/103 • Number of events 3
|
6.2%
1/16 • Number of events 2
|
0.00%
0/59
|
0.00%
0/36
|
|
Psychiatric disorders
DEPRESSION
|
21.2%
22/104 • Number of events 25
|
20.6%
22/107 • Number of events 29
|
19.4%
20/103 • Number of events 23
|
28.2%
29/103 • Number of events 34
|
19.4%
20/103 • Number of events 26
|
6.2%
1/16 • Number of events 1
|
23.7%
14/59 • Number of events 17
|
11.1%
4/36 • Number of events 5
|
|
Psychiatric disorders
INSOMNIA
|
38.5%
40/104 • Number of events 50
|
33.6%
36/107 • Number of events 40
|
28.2%
29/103 • Number of events 37
|
38.8%
40/103 • Number of events 46
|
39.8%
41/103 • Number of events 48
|
43.8%
7/16 • Number of events 7
|
39.0%
23/59 • Number of events 27
|
19.4%
7/36 • Number of events 7
|
|
Psychiatric disorders
MOOD SWINGS
|
1.9%
2/104 • Number of events 3
|
0.93%
1/107 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
2.9%
3/103 • Number of events 4
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
0.00%
0/36
|
|
Renal and urinary disorders
CHROMATURIA
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/104
|
0.00%
0/107
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.96%
1/104 • Number of events 1
|
3.7%
4/107 • Number of events 4
|
5.8%
6/103 • Number of events 6
|
2.9%
3/103 • Number of events 3
|
5.8%
6/103 • Number of events 6
|
12.5%
2/16 • Number of events 2
|
8.5%
5/59 • Number of events 5
|
0.00%
0/36
|
|
Renal and urinary disorders
URETHRAL OBSTRUCTION
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/104
|
0.00%
0/107
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
1.9%
2/104 • Number of events 2
|
1.9%
2/107 • Number of events 2
|
0.00%
0/103
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
8.5%
5/59 • Number of events 5
|
0.00%
0/36
|
|
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
19.2%
20/104 • Number of events 26
|
16.8%
18/107 • Number of events 27
|
21.4%
22/103 • Number of events 25
|
16.5%
17/103 • Number of events 21
|
18.4%
19/103 • Number of events 25
|
12.5%
2/16 • Number of events 2
|
13.6%
8/59 • Number of events 9
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
14.4%
15/104 • Number of events 20
|
16.8%
18/107 • Number of events 23
|
11.7%
12/103 • Number of events 12
|
15.5%
16/103 • Number of events 21
|
19.4%
20/103 • Number of events 25
|
25.0%
4/16 • Number of events 4
|
16.9%
10/59 • Number of events 14
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.8%
6/104 • Number of events 6
|
5.6%
6/107 • Number of events 6
|
1.9%
2/103 • Number of events 2
|
4.9%
5/103 • Number of events 6
|
10.7%
11/103 • Number of events 14
|
6.2%
1/16 • Number of events 1
|
6.8%
4/59 • Number of events 4
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.9%
3/104 • Number of events 3
|
2.8%
3/107 • Number of events 4
|
1.9%
2/103 • Number of events 2
|
5.8%
6/103 • Number of events 7
|
2.9%
3/103 • Number of events 3
|
0.00%
0/16
|
3.4%
2/59 • Number of events 2
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED UPPER AIRWAY SECRETION
|
0.00%
0/104
|
0.00%
0/107
|
2.9%
3/103 • Number of events 3
|
1.9%
2/103 • Number of events 2
|
1.9%
2/103 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
2.9%
3/104 • Number of events 3
|
1.9%
2/107 • Number of events 2
|
10.7%
11/103 • Number of events 12
|
8.7%
9/103 • Number of events 10
|
4.9%
5/103 • Number of events 5
|
12.5%
2/16 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
0.96%
1/104 • Number of events 1
|
1.9%
2/107 • Number of events 2
|
0.00%
0/103
|
0.00%
0/103
|
0.00%
0/103
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
4.8%
5/104 • Number of events 5
|
1.9%
2/107 • Number of events 2
|
0.00%
0/103
|
1.9%
2/103 • Number of events 2
|
3.9%
4/103 • Number of events 5
|
0.00%
0/16
|
5.1%
3/59 • Number of events 5
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
1.9%
2/104 • Number of events 3
|
0.93%
1/107 • Number of events 1
|
2.9%
3/103 • Number of events 3
|
2.9%
3/103 • Number of events 3
|
3.9%
4/103 • Number of events 4
|
6.2%
1/16 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
26.0%
27/104 • Number of events 28
|
33.6%
36/107 • Number of events 41
|
29.1%
30/103 • Number of events 34
|
29.1%
30/103 • Number of events 31
|
34.0%
35/103 • Number of events 38
|
31.2%
5/16 • Number of events 5
|
32.2%
19/59 • Number of events 19
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
3.8%
4/104 • Number of events 5
|
0.93%
1/107 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
3.9%
4/103 • Number of events 5
|
0.97%
1/103 • Number of events 1
|
12.5%
2/16 • Number of events 4
|
3.4%
2/59 • Number of events 2
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
16.3%
17/104 • Number of events 17
|
11.2%
12/107 • Number of events 14
|
8.7%
9/103 • Number of events 10
|
21.4%
22/103 • Number of events 24
|
16.5%
17/103 • Number of events 18
|
18.8%
3/16 • Number of events 3
|
15.3%
9/59 • Number of events 13
|
11.1%
4/36 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
3.8%
4/104 • Number of events 7
|
1.9%
2/107 • Number of events 2
|
6.8%
7/103 • Number of events 8
|
2.9%
3/103 • Number of events 4
|
3.9%
4/103 • Number of events 4
|
12.5%
2/16 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
2.9%
3/104 • Number of events 3
|
3.7%
4/107 • Number of events 4
|
5.8%
6/103 • Number of events 6
|
2.9%
3/103 • Number of events 3
|
1.9%
2/103 • Number of events 2
|
0.00%
0/16
|
0.00%
0/59
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
INCREASED TENDENCY TO BRUISE
|
0.00%
0/104
|
0.93%
1/107 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
15.4%
16/104 • Number of events 20
|
17.8%
19/107 • Number of events 23
|
18.4%
19/103 • Number of events 28
|
22.3%
23/103 • Number of events 35
|
18.4%
19/103 • Number of events 24
|
6.2%
1/16 • Number of events 1
|
18.6%
11/59 • Number of events 17
|
8.3%
3/36 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.8%
6/104 • Number of events 7
|
2.8%
3/107 • Number of events 5
|
5.8%
6/103 • Number of events 6
|
8.7%
9/103 • Number of events 12
|
8.7%
9/103 • Number of events 9
|
6.2%
1/16 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
1.9%
2/104 • Number of events 3
|
6.5%
7/107 • Number of events 9
|
4.9%
5/103 • Number of events 6
|
3.9%
4/103 • Number of events 9
|
2.9%
3/103 • Number of events 3
|
0.00%
0/16
|
3.4%
2/59 • Number of events 3
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/104
|
1.9%
2/107 • Number of events 2
|
2.9%
3/103 • Number of events 3
|
5.8%
6/103 • Number of events 9
|
5.8%
6/103 • Number of events 7
|
0.00%
0/16
|
3.4%
2/59 • Number of events 3
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
4.8%
5/104 • Number of events 7
|
5.6%
6/107 • Number of events 7
|
0.97%
1/103 • Number of events 1
|
4.9%
5/103 • Number of events 5
|
3.9%
4/103 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
13.6%
8/59 • Number of events 9
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
7.7%
8/104 • Number of events 10
|
8.4%
9/107 • Number of events 9
|
7.8%
8/103 • Number of events 9
|
16.5%
17/103 • Number of events 23
|
13.6%
14/103 • Number of events 17
|
6.2%
1/16 • Number of events 1
|
6.8%
4/59 • Number of events 6
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
3.8%
4/104 • Number of events 5
|
0.93%
1/107 • Number of events 1
|
3.9%
4/103 • Number of events 4
|
0.97%
1/103 • Number of events 1
|
4.9%
5/103 • Number of events 6
|
6.2%
1/16 • Number of events 1
|
8.5%
5/59 • Number of events 7
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
3.8%
4/104 • Number of events 4
|
3.7%
4/107 • Number of events 4
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
1.9%
2/103 • Number of events 4
|
0.00%
0/16
|
1.7%
1/59 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
1.9%
2/104 • Number of events 2
|
2.8%
3/107 • Number of events 3
|
0.00%
0/103
|
0.00%
0/103
|
0.97%
1/103 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
0.00%
0/59
|
0.00%
0/36
|
|
Vascular disorders
HYPERTENSION
|
5.8%
6/104 • Number of events 6
|
1.9%
2/107 • Number of events 2
|
3.9%
4/103 • Number of events 4
|
0.97%
1/103 • Number of events 1
|
4.9%
5/103 • Number of events 5
|
0.00%
0/16
|
5.1%
3/59 • Number of events 4
|
0.00%
0/36
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/104
|
2.8%
3/107 • Number of events 4
|
0.97%
1/103 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
2.9%
3/103 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
0.00%
0/59
|
0.00%
0/36
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator agrees to provide to the sponsor thirty (30) days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including slides and texts of oral or other public presentations and texts of any transmission through any electronic media) that report any results of the study.
- Publication restrictions are in place
Restriction type: OTHER