Trial Outcomes & Findings for A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION) (NCT NCT01280656)
NCT ID: NCT01280656
Last Updated: 2016-11-29
Results Overview
Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \[HCV RNA\] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
Recruitment status
COMPLETED
Target enrollment
660 participants
Primary outcome timeframe
At Week 60
Results posted on
2016-11-29
Participant Flow
A total of 660 participants were enrolled from 39 centers in Brazil. The study was conducted from January 2010 to June 2013.
Participant milestones
| Measure |
Conventional Interferon Plus Ribavirin
Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
312
|
286
|
|
Overall Study
COMPLETED
|
59
|
265
|
223
|
|
Overall Study
NOT COMPLETED
|
3
|
47
|
63
|
Reasons for withdrawal
| Measure |
Conventional Interferon Plus Ribavirin
Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
14
|
13
|
|
Overall Study
Lack of Efficacy
|
1
|
22
|
38
|
|
Overall Study
Treatment shortening (RGT)
|
0
|
4
|
5
|
|
Overall Study
Other
|
1
|
7
|
7
|
Baseline Characteristics
A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)
Baseline characteristics by cohort
| Measure |
Conventional Interferon Plus Ribavirin
n=62 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=312 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=286 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Total
n=660 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
357 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
303 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Week 60Population: The intent-to-treat (ITT) population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).
Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \[HCV RNA\] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=16 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=126 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=101 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment
|
0 percentage of participants
|
7.1 percentage of participants
|
20.8 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 72Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).
SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \[HCV RNA\] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=16 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=126 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=101 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment
|
62.5 percentage of participants
|
74.6 percentage of participants
|
72.3 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 24Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in the participants who were available for interferon dose reduction rates in each group (56, 302, and 280 respectively).
The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=56 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=302 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=280 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used
|
1 participants
|
9 participants
|
29 participants
|
SECONDARY outcome
Timeframe: At Week 12Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=62 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=312 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=286 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Early Virologic Response at Week 12
|
14.5 percentage of participants
|
37.2 percentage of participants
|
35.0 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 60 (SVR 12) and Week 72 (SVR 24)Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group excluding participants treated at an unknown location (2/16, 5/126, and 9/101 respectively).
The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=14 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=121 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=92 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home
SVR-12, treated at IAC (n=0, 40, 35)
|
NA percentage of participants
No participants were available for analysis in this arm.
|
5.0 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home
SVR-12, treated at home (n=14, 81, 57)
|
0 percentage of participants
|
8.6 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home
SVR-24, treated at IAC (n=0, 40, 35)
|
NA percentage of participants
No participants were available for analysis in this arm.
|
80.0 percentage of participants
|
77.1 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home
SVR-24, treated at home (n=14, 81, 57)
|
64.3 percentage of participants
|
75.3 percentage of participants
|
68.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis excluded participants treated at an unknown location (7/62, 10/312, and 23/286 respectively)
The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=55 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=302 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=263 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment
At the site (n=0,98,126)
|
NA percentage of participants
No participants were available for analysis in this arm.
|
17.4 percentage of participants
|
17.5 percentage of participants
|
|
Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment
At home (n=55,204,137)
|
5.5 percentage of participants
|
11.8 percentage of participants
|
21.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. Treatment responders and non-responders for whom data was available were considered for this outcome measure.
The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=10 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=73 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=63 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders
Responders (n=0,19,15)
|
NA mean percentage reduction of hemoglobin
Standard Deviation NA
No participants were available for analysis in this arm.
|
14.4 mean percentage reduction of hemoglobin
Standard Deviation 8.5
|
15.8 mean percentage reduction of hemoglobin
Standard Deviation 10.3
|
|
Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders
Non-responders (n=10,54,48)
|
18.3 mean percentage reduction of hemoglobin
Standard Deviation 9.5
|
9.8 mean percentage reduction of hemoglobin
Standard Deviation 27.7
|
12.6 mean percentage reduction of hemoglobin
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: At Week 4Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=62 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=312 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=286 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Rapid Virologic Response at Week 4
|
6.5 percentage of participants
|
21.2 percentage of participants
|
20.3 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 48Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=62 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=312 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=286 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Virologic Response at End of Treatment
|
25.8 percentage of participants
|
40.4 percentage of participants
|
35.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).
Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=16 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=126 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=101 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Virologic Relapse up to Week 72
|
37.5 percentage of participants
|
22.2 percentage of participants
|
22.8 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 48Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=62 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=312 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=286 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Null Response or No Responder at End of Treatment
|
74.2 percentage of participants
|
59.6 percentage of participants
|
64.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=62 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=312 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=286 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued Treatment Due to Adverse Events
|
1.6 percentage of participants
|
4.5 percentage of participants
|
4.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
Outcome measures
| Measure |
Conventional Interferon Plus Ribavirin
n=62 Participants
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2a Plus Ribavirin
n=312 Participants
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
Peginterferon Alfa-2b Plus Ribavirin
n=286 Participants
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
|
|---|---|---|---|
|
Number of Participants With Any Adverse Events and Any Serious Adverse Events
any AE
|
57 participants
|
285 participants
|
264 participants
|
|
Number of Participants With Any Adverse Events and Any Serious Adverse Events
any SAE
|
2 participants
|
15 participants
|
9 participants
|
Adverse Events
Conventional Interferon Plus Ribavirin
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Peginterferon Alfa-2a Plus Ribavirin
Serious events: 15 serious events
Other events: 275 other events
Deaths: 0 deaths
Peginterferon Alfa-2b Plus Ribavirin
Serious events: 9 serious events
Other events: 262 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conventional Interferon Plus Ribavirin
n=62 participants at risk
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
|
Peginterferon Alfa-2a Plus Ribavirin
n=312 participants at risk
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy
|
Peginterferon Alfa-2b Plus Ribavirin
n=286 participants at risk
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
|
|---|---|---|---|
|
Hepatobiliary disorders
Gallstones
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.35%
1/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Cardiac disorders
Thoracic pain
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.35%
1/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.35%
1/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
1.0%
3/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Blood and lymphatic system disorders
Neutropaenia
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.35%
1/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Blood and lymphatic system disorders
Febrile neutropaenia
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.35%
1/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Blood and lymphatic system disorders
Thrombocytopaenia
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.35%
1/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Immune system disorders
Cryoglobulinaemia
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.6%
1/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.35%
1/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.35%
1/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Infections and infestations
Cell tissue inflammation
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal cord neoplasia
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast tumour
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Psychiatric disorders
Depression
|
1.6%
1/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.32%
1/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
0.00%
0/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
Other adverse events
| Measure |
Conventional Interferon Plus Ribavirin
n=62 participants at risk
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
|
Peginterferon Alfa-2a Plus Ribavirin
n=312 participants at risk
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy
|
Peginterferon Alfa-2b Plus Ribavirin
n=286 participants at risk
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.9%
8/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
9.0%
28/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
9.1%
26/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Skin and subcutaneous tissue disorders
Itch
|
14.5%
9/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
16.0%
50/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
15.4%
44/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
6/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
5.1%
16/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
5.6%
16/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremities
|
1.6%
1/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
4.8%
15/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
5.6%
16/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Musculoskeletal and connective tissue disorders
Dorsalgia
|
1.6%
1/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
2.9%
9/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
6.6%
19/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.9%
8/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
16.3%
51/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
11.5%
33/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.4%
12/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
24.0%
75/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
18.2%
52/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Metabolism and nutrition disorders
Cachexia
|
3.2%
2/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
2.9%
9/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
5.9%
17/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Blood and lymphatic system disorders
Anaemia
|
17.7%
11/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
34.9%
109/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
38.8%
111/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Blood and lymphatic system disorders
Leucopaenia
|
1.6%
1/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
4.5%
14/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
7.0%
20/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Blood and lymphatic system disorders
Neutropaenia
|
4.8%
3/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
19.2%
60/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
15.7%
45/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Blood and lymphatic system disorders
Thrombocytopaenia
|
4.8%
3/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
8.7%
27/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
7.3%
21/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Nervous system disorders
Headache
|
30.6%
19/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
21.5%
67/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
23.4%
67/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Nervous system disorders
Insomnia
|
9.7%
6/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
13.8%
43/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
10.5%
30/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Nervous system disorders
Dizziness
|
8.1%
5/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
9.0%
28/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
8.7%
25/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
3/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
6.7%
21/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
9.4%
27/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
3.2%
10/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
5.6%
16/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Gastrointestinal disorders
High abdominal pain
|
11.3%
7/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
8.0%
25/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
8.0%
23/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Gastrointestinal disorders
Nausea
|
16.1%
10/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
18.3%
57/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
15.7%
45/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Gastrointestinal disorders
Vomiting
|
11.3%
7/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
6.7%
21/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
7.0%
20/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
7.4%
23/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
3.8%
11/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Psychiatric disorders
Anxiety
|
3.2%
2/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
3.8%
12/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
6.6%
19/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Psychiatric disorders
Depression
|
3.2%
2/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
11.5%
36/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
12.2%
35/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
Psychiatric disorders
Irritability
|
6.5%
4/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
13.1%
41/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
10.8%
31/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
General disorders
Asthenia
|
37.1%
23/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
36.5%
114/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
37.4%
107/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
General disorders
Pain
|
4.8%
3/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
6.1%
19/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
10.5%
30/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
General disorders
Flu condition
|
4.8%
3/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
8.0%
25/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
17.5%
50/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
General disorders
Fatigue
|
14.5%
9/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
11.5%
36/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
12.2%
35/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
General disorders
Malaise
|
11.3%
7/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
6.1%
19/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
7.3%
21/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
|
General disorders
Pyrexia
|
25.8%
16/62 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
20.8%
65/312 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
23.1%
66/286 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in ITT population set.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER