Trial Outcomes & Findings for Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471) (NCT NCT00081770)
NCT ID: NCT00081770
Last Updated: 2017-04-04
Results Overview
SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4469 participants
Primary outcome timeframe
Assessed at the end of a 24-week post-treatment follow-up
Results posted on
2017-04-04
Participant Flow
Enrolled 4469 subjects; Randomized 3083; Treated 3070
Participant milestones
| Measure |
PegIntron 1.5 ug/kg/wk Plus REBETOL
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PegIntron 1.0 ug/kg/wk Plus REBETOL
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PEGASYS 180 ug/wk Plus COPEGUS
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
|---|---|---|---|
|
Overall Study
STARTED
|
1019
|
1016
|
1035
|
|
Overall Study
COMPLETED
|
517
|
470
|
579
|
|
Overall Study
NOT COMPLETED
|
502
|
546
|
456
|
Reasons for withdrawal
| Measure |
PegIntron 1.5 ug/kg/wk Plus REBETOL
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PegIntron 1.0 ug/kg/wk Plus REBETOL
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PEGASYS 180 ug/wk Plus COPEGUS
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
130
|
98
|
136
|
|
Overall Study
Lack of Efficacy
|
262
|
357
|
211
|
|
Overall Study
Lost to Follow-up
|
45
|
34
|
45
|
|
Overall Study
Protocol Violation
|
15
|
10
|
10
|
|
Overall Study
Withdrawal by Subject
|
45
|
40
|
42
|
|
Overall Study
Did not meet protocol eligibility
|
2
|
0
|
3
|
|
Overall Study
Administrative
|
1
|
0
|
1
|
|
Overall Study
Other
|
2
|
7
|
8
|
Baseline Characteristics
Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
Baseline characteristics by cohort
| Measure |
PegIntron 1.5 ug/kg/wk Plus REBETOL
n=1019 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PegIntron 1.0 ug/kg/wk Plus REBETOL
n=1016 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PEGASYS 180 ug/wk Plus COPEGUS
n=1035 Participants
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
Total
n=3070 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 7.8 • n=93 Participants
|
47.5 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
47.6 years
STANDARD_DEVIATION 8.2 • n=27 Participants
|
47.5 years
STANDARD_DEVIATION 8.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
406 Participants
n=93 Participants
|
409 Participants
n=4 Participants
|
422 Participants
n=27 Participants
|
1237 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
613 Participants
n=93 Participants
|
607 Participants
n=4 Participants
|
613 Participants
n=27 Participants
|
1833 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Assessed at the end of a 24-week post-treatment follow-upPopulation: Intent-to-Treat \[ITT\] Population defined as subjects who received at least one dose of study medication
SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.
Outcome measures
| Measure |
PegIntron 1.5 ug/kg/wk Plus REBETOL
n=1019 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PegIntron 1.0 ug/kg/wk Plus REBETOL
n=1016 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PEGASYS 180 ug/wk Plus COPEGUS
n=1035 Participants
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
|---|---|---|---|
|
Sustained Virologic Response (SVR) Rate
|
39.8 Percentage of participants
|
38.0 Percentage of participants
|
40.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Assessed at Baseline and Treatment Week 4Population: ITT Population defined as subjects who received at least one dose of study medication
The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.
Outcome measures
| Measure |
PegIntron 1.5 ug/kg/wk Plus REBETOL
n=1019 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PegIntron 1.0 ug/kg/wk Plus REBETOL
n=1016 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PEGASYS 180 ug/wk Plus COPEGUS
n=1035 Participants
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
|---|---|---|---|
|
Mean Change From Baseline in the Log Viral Load at Treatment Week 4
|
-2.32 Log10 IU/mL
Standard Deviation 1.50
|
-2.02 Log10 IU/mL
Standard Deviation 1.42
|
-2.45 Log10 IU/mL
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: Assessed at Treatment Week 12Population: ITT Population defined as subjects who received at least one dose of study medication
Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12
Outcome measures
| Measure |
PegIntron 1.5 ug/kg/wk Plus REBETOL
n=1019 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PegIntron 1.0 ug/kg/wk Plus REBETOL
n=1016 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PEGASYS 180 ug/wk Plus COPEGUS
n=1035 Participants
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
|---|---|---|---|
|
Virologic Response Rate at Treatment Week 12
|
39.9 Percentage of participants
|
36.0 Percentage of participants
|
45.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Assessed at Baseline and Treatment Week 2Population: ITT Population defined as subjects who received at least one dose of study medication
The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.
Outcome measures
| Measure |
PegIntron 1.5 ug/kg/wk Plus REBETOL
n=1019 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PegIntron 1.0 ug/kg/wk Plus REBETOL
n=1016 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
PEGASYS 180 ug/wk Plus COPEGUS
n=1035 Participants
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
|
|---|---|---|---|
|
Mean Change From Baseline in the Log Viral Load at Treatment Week 2
|
-1.55 Log10 IU/mL
Standard Deviation 1.20
|
-1.30 Log10 IU/mL
Standard Deviation 1.12
|
-1.60 Log10 IU/mL
Standard Deviation 1.24
|
Adverse Events
PegIntron 1.5 ug/kg/wk Plus REBETOL
Serious events: 88 serious events
Other events: 996 other events
Deaths: 0 deaths
PegIntron 1.0 ug/kg/wk Plus REBETOL
Serious events: 94 serious events
Other events: 1000 other events
Deaths: 0 deaths
PEGASYS 180 ug/wk Plus COPEGUS
Serious events: 121 serious events
Other events: 1018 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegIntron 1.5 ug/kg/wk Plus REBETOL
n=1019 participants at risk
|
PegIntron 1.0 ug/kg/wk Plus REBETOL
n=1016 participants at risk
|
PEGASYS 180 ug/wk Plus COPEGUS
n=1035 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.29%
3/1019 • Number of events 3
|
0.30%
3/1016 • Number of events 3
|
0.10%
1/1035 • Number of events 1
|
|
Blood and lymphatic system disorders
APLASTIC ANAEMIA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.19%
2/1035 • Number of events 2
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Cardiac disorders
CORONARY ARTERY RESTENOSIS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Cardiac disorders
CYANOSIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.20%
2/1019 • Number of events 2
|
0.20%
2/1016 • Number of events 2
|
0.19%
2/1035 • Number of events 2
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/1019
|
0.20%
2/1016 • Number of events 2
|
0.00%
0/1035
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Cardiac disorders
WOLFF-PARKINSON-WHITE SYNDROME
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Eye disorders
CATARACT
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 2
|
|
Eye disorders
MACULOPATHY
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Eye disorders
PAPILLOEDEMA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.20%
2/1019 • Number of events 3
|
0.39%
4/1016 • Number of events 5
|
0.39%
4/1035 • Number of events 4
|
|
Gastrointestinal disorders
APPENDICITIS PERFORATED
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
COLITIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
EROSIVE OESOPHAGITIS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
ILEUS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.10%
1/1019 • Number of events 1
|
0.20%
2/1016 • Number of events 2
|
0.00%
0/1035
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.48%
5/1035 • Number of events 5
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATIC CYST
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATIC ENLARGEMENT
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATIC MASS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.10%
1/1019 • Number of events 1
|
0.20%
2/1016 • Number of events 2
|
0.00%
0/1035
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Gastrointestinal disorders
PERITONEAL HAEMORRHAGE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Gastrointestinal disorders
SALIVARY DUCT OBSTRUCTION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/1019
|
0.30%
3/1016 • Number of events 3
|
0.39%
4/1035 • Number of events 4
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/1019
|
0.20%
2/1016 • Number of events 2
|
0.29%
3/1035 • Number of events 3
|
|
General disorders
CHEST PAIN
|
0.79%
8/1019 • Number of events 8
|
0.79%
8/1016 • Number of events 8
|
0.77%
8/1035 • Number of events 8
|
|
General disorders
DEATH
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
General disorders
FACE OEDEMA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
General disorders
FATIGUE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
General disorders
HERNIA OBSTRUCTIVE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.10%
1/1019 • Number of events 1
|
0.20%
2/1016 • Number of events 2
|
0.10%
1/1035 • Number of events 1
|
|
General disorders
PYREXIA
|
0.20%
2/1019 • Number of events 2
|
0.20%
2/1016 • Number of events 2
|
0.00%
0/1035
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Hepatobiliary disorders
BILIARY DYSKINESIA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.29%
3/1019 • Number of events 3
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.49%
5/1019 • Number of events 5
|
0.30%
3/1016 • Number of events 3
|
0.29%
3/1035 • Number of events 3
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 2
|
|
Hepatobiliary disorders
PORTAL HYPERTENSIVE GASTROPATHY
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Immune system disorders
SARCOIDOSIS
|
0.20%
2/1019 • Number of events 2
|
0.10%
1/1016 • Number of events 1
|
0.29%
3/1035 • Number of events 3
|
|
Infections and infestations
ABDOMINAL WALL INFECTION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
ANOGENITAL WARTS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
APPENDICITIS
|
0.20%
2/1019 • Number of events 2
|
0.39%
4/1016 • Number of events 4
|
0.39%
4/1035 • Number of events 5
|
|
Infections and infestations
BLASTOMYCOSIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
BURSITIS INFECTIVE STAPHYLOCOCCAL
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
0.20%
2/1019 • Number of events 2
|
0.49%
5/1016 • Number of events 5
|
0.58%
6/1035 • Number of events 6
|
|
Infections and infestations
CHOLECYSTITIS INFECTIVE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
ENCEPHALITIS VIRAL
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
HERPES OESOPHAGITIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Infections and infestations
INFECTION
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
INFECTIVE TENOSYNOVITIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
INJECTION SITE ABSCESS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Infections and infestations
INJECTION SITE CELLULITIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Infections and infestations
KIDNEY INFECTION
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
LUNG ABSCESS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Infections and infestations
MENINGITIS VIRAL
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
ORCHITIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
PERITONEAL ABSCESS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.19%
2/1035 • Number of events 2
|
|
Infections and infestations
PNEUMONIA
|
0.20%
2/1019 • Number of events 2
|
0.30%
3/1016 • Number of events 3
|
0.58%
6/1035 • Number of events 6
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.00%
0/1019
|
0.00%
0/1016
|
0.29%
3/1035 • Number of events 3
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/1019
|
0.20%
2/1016 • Number of events 2
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
SEPSIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
SEPSIS SYNDROME
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
SINUSITIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Infections and infestations
STAPHYLOCOCCAL ABSCESS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.19%
2/1035 • Number of events 2
|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Infections and infestations
VIRAL INFECTION
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Injury, poisoning and procedural complications
BACK INJURY
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Injury, poisoning and procedural complications
DRUG TOXICITY
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 2
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
FALL
|
0.10%
1/1019 • Number of events 1
|
0.30%
3/1016 • Number of events 3
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
GUN SHOT WOUND
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
HEPATIC HAEMATOMA
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
HUMAN BITE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
JAW FRACTURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 3
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
LUNG INJURY
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/1019
|
0.20%
2/1016 • Number of events 2
|
0.19%
2/1035 • Number of events 2
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL BILE LEAK
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 2
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.10%
1/1019 • Number of events 1
|
0.30%
3/1016 • Number of events 3
|
0.10%
1/1035 • Number of events 1
|
|
Injury, poisoning and procedural complications
SCAPULA FRACTURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Injury, poisoning and procedural complications
THERAPEUTIC AGENT TOXICITY
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Injury, poisoning and procedural complications
TRAUMATIC BRAIN INJURY
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Investigations
GRIP STRENGTH DECREASED
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.10%
1/1019 • Number of events 1
|
0.20%
2/1016 • Number of events 2
|
0.29%
3/1035 • Number of events 3
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.19%
2/1035 • Number of events 2
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/1019
|
0.20%
2/1016 • Number of events 2
|
0.00%
0/1035
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Musculoskeletal and connective tissue disorders
GOUTY ARTHRITIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
JOINT INSTABILITY
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
WEIGHT BEARING DIFFICULTY
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACOUSTIC NEUROMA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.19%
2/1035 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA OF LIVER
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.00%
0/1019
|
0.00%
0/1016
|
0.19%
2/1035 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM OF AMPULLA OF VATER
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OROPHARYNGEAL CANCER STAGE UNSPECIFIED
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN ADENOMA
|
0.10%
1/1019 • Number of events 2
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Nervous system disorders
AKATHISIA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
ANOXIC ENCEPHALOPATHY
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
COMA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.19%
2/1035 • Number of events 2
|
|
Nervous system disorders
DIZZINESS
|
0.20%
2/1019 • Number of events 2
|
0.20%
2/1016 • Number of events 2
|
0.00%
0/1035
|
|
Nervous system disorders
DYSARTHRIA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Nervous system disorders
FACIAL PALSY
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 2
|
|
Nervous system disorders
INTRACRANIAL ANEURYSM
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 2
|
0.00%
0/1035
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 2
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
PARAPLEGIA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
PERONEAL NERVE PALSY
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Nervous system disorders
PRESYNCOPE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Nervous system disorders
SPINAL CORD INFARCTION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 2
|
|
Nervous system disorders
SYNCOPE
|
0.39%
4/1019 • Number of events 4
|
0.10%
1/1016 • Number of events 1
|
0.29%
3/1035 • Number of events 3
|
|
Nervous system disorders
SYNCOPE VASOVAGAL
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/1019
|
0.30%
3/1016 • Number of events 3
|
0.00%
0/1035
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Psychiatric disorders
ANGER
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Psychiatric disorders
ANXIETY
|
0.20%
2/1019 • Number of events 2
|
0.20%
2/1016 • Number of events 2
|
0.10%
1/1035 • Number of events 1
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.29%
3/1019 • Number of events 3
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Psychiatric disorders
DEPENDENCE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Psychiatric disorders
DEPRESSION
|
0.49%
5/1019 • Number of events 9
|
0.30%
3/1016 • Number of events 3
|
0.29%
3/1035 • Number of events 3
|
|
Psychiatric disorders
DISORIENTATION
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Psychiatric disorders
DRUG ABUSE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.19%
2/1035 • Number of events 2
|
|
Psychiatric disorders
DRUG DEPENDENCE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Psychiatric disorders
HALLUCINATION
|
0.20%
2/1019 • Number of events 2
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Psychiatric disorders
HALLUCINATION, AUDITORY
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Psychiatric disorders
HOMICIDAL IDEATION
|
0.20%
2/1019 • Number of events 3
|
0.20%
2/1016 • Number of events 2
|
0.00%
0/1035
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Psychiatric disorders
PARANOIA
|
0.20%
2/1019 • Number of events 2
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
1.3%
13/1019 • Number of events 17
|
0.79%
8/1016 • Number of events 8
|
0.48%
5/1035 • Number of events 5
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.19%
2/1035 • Number of events 2
|
|
Renal and urinary disorders
BLADDER DISORDER
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.20%
2/1019 • Number of events 2
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Renal and urinary disorders
RENAL PAIN
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.10%
1/1019 • Number of events 1
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Reproductive system and breast disorders
RECTOCELE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Reproductive system and breast disorders
VAGINAL PROLAPSE
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.10%
1/1019 • Number of events 1
|
0.20%
2/1016 • Number of events 2
|
0.19%
2/1035 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.20%
2/1019 • Number of events 2
|
0.49%
5/1016 • Number of events 5
|
0.29%
3/1035 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.20%
2/1019 • Number of events 2
|
0.00%
0/1016
|
0.29%
3/1035 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY SARCOIDOSIS
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Social circumstances
PHYSICAL ASSAULT
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.00%
0/1035
|
|
Surgical and medical procedures
CYSTOPEXY
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Surgical and medical procedures
HYSTERECTOMY
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Surgical and medical procedures
RECTOCELE REPAIR
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Surgical and medical procedures
SALPINGO-OOPHORECTOMY UNILATERAL
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
|
Surgical and medical procedures
SPINAL FUSION SURGERY
|
0.00%
0/1019
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/1019
|
0.10%
1/1016 • Number of events 1
|
0.10%
1/1035 • Number of events 1
|
|
Vascular disorders
HYPERTENSION
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Vascular disorders
HYPOTENSION
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.10%
1/1035 • Number of events 1
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.10%
1/1019 • Number of events 1
|
0.00%
0/1016
|
0.00%
0/1035
|
Other adverse events
| Measure |
PegIntron 1.5 ug/kg/wk Plus REBETOL
n=1019 participants at risk
|
PegIntron 1.0 ug/kg/wk Plus REBETOL
n=1016 participants at risk
|
PEGASYS 180 ug/wk Plus COPEGUS
n=1035 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
33.8%
344/1019 • Number of events 555
|
28.6%
291/1016 • Number of events 442
|
33.6%
348/1035 • Number of events 556
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
9.3%
95/1019 • Number of events 153
|
6.8%
69/1016 • Number of events 109
|
10.2%
106/1035 • Number of events 206
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
25.8%
263/1019 • Number of events 466
|
18.5%
188/1016 • Number of events 300
|
31.4%
325/1035 • Number of events 670
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.8%
29/1019 • Number of events 38
|
2.4%
24/1016 • Number of events 45
|
6.2%
64/1035 • Number of events 111
|
|
Endocrine disorders
HYPOTHYROIDISM
|
5.5%
56/1019 • Number of events 61
|
3.8%
39/1016 • Number of events 42
|
4.6%
48/1035 • Number of events 51
|
|
Eye disorders
VISION BLURRED
|
4.5%
46/1019 • Number of events 52
|
6.1%
62/1016 • Number of events 69
|
7.1%
74/1035 • Number of events 76
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.6%
47/1019 • Number of events 59
|
5.2%
53/1016 • Number of events 60
|
5.9%
61/1035 • Number of events 70
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.0%
51/1019 • Number of events 60
|
4.9%
50/1016 • Number of events 55
|
5.2%
54/1035 • Number of events 69
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.6%
77/1019 • Number of events 85
|
8.2%
83/1016 • Number of events 89
|
6.1%
63/1035 • Number of events 68
|
|
Gastrointestinal disorders
DIARRHOEA
|
16.7%
170/1019 • Number of events 221
|
19.0%
193/1016 • Number of events 230
|
16.7%
173/1035 • Number of events 207
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.7%
58/1019 • Number of events 60
|
5.2%
53/1016 • Number of events 53
|
4.8%
50/1035 • Number of events 52
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.9%
60/1019 • Number of events 62
|
6.1%
62/1016 • Number of events 72
|
6.7%
69/1035 • Number of events 78
|
|
Gastrointestinal disorders
NAUSEA
|
42.5%
433/1019 • Number of events 517
|
37.1%
377/1016 • Number of events 462
|
36.2%
375/1035 • Number of events 434
|
|
Gastrointestinal disorders
VOMITING
|
14.7%
150/1019 • Number of events 190
|
12.0%
122/1016 • Number of events 149
|
11.5%
119/1035 • Number of events 141
|
|
General disorders
ASTHENIA
|
5.0%
51/1019 • Number of events 57
|
4.3%
44/1016 • Number of events 48
|
4.0%
41/1035 • Number of events 43
|
|
General disorders
CHILLS
|
39.0%
397/1019 • Number of events 428
|
35.9%
365/1016 • Number of events 421
|
23.5%
243/1035 • Number of events 266
|
|
General disorders
FATIGUE
|
65.9%
672/1019 • Number of events 798
|
66.5%
676/1016 • Number of events 802
|
63.4%
656/1035 • Number of events 809
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
16.1%
164/1019 • Number of events 203
|
15.2%
154/1016 • Number of events 175
|
15.5%
160/1035 • Number of events 182
|
|
General disorders
INJECTION SITE ERYTHEMA
|
16.3%
166/1019 • Number of events 172
|
17.5%
178/1016 • Number of events 197
|
11.9%
123/1035 • Number of events 125
|
|
General disorders
INJECTION SITE REACTION
|
10.0%
102/1019 • Number of events 118
|
11.0%
112/1016 • Number of events 116
|
5.6%
58/1035 • Number of events 62
|
|
General disorders
IRRITABILITY
|
25.1%
256/1019 • Number of events 317
|
25.8%
262/1016 • Number of events 319
|
25.3%
262/1035 • Number of events 314
|
|
General disorders
PAIN
|
12.4%
126/1019 • Number of events 156
|
13.6%
138/1016 • Number of events 168
|
9.7%
100/1035 • Number of events 124
|
|
General disorders
PYREXIA
|
34.9%
356/1019 • Number of events 417
|
32.6%
331/1016 • Number of events 381
|
22.9%
237/1035 • Number of events 264
|
|
Infections and infestations
BRONCHITIS
|
3.3%
34/1019 • Number of events 37
|
3.1%
32/1016 • Number of events 39
|
5.8%
60/1035 • Number of events 66
|
|
Infections and infestations
SINUSITIS
|
5.8%
59/1019 • Number of events 72
|
4.2%
43/1016 • Number of events 53
|
7.0%
72/1035 • Number of events 90
|
|
Investigations
WEIGHT DECREASED
|
13.5%
138/1019 • Number of events 164
|
10.3%
105/1016 • Number of events 122
|
9.9%
102/1035 • Number of events 116
|
|
Metabolism and nutrition disorders
ANOREXIA
|
11.9%
121/1019 • Number of events 131
|
9.4%
96/1016 • Number of events 100
|
7.3%
76/1035 • Number of events 81
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
18.1%
184/1019 • Number of events 197
|
15.6%
159/1016 • Number of events 167
|
13.7%
142/1035 • Number of events 152
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
23.4%
238/1019 • Number of events 296
|
23.3%
237/1016 • Number of events 294
|
24.2%
250/1035 • Number of events 307
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.3%
105/1019 • Number of events 118
|
10.4%
106/1016 • Number of events 125
|
11.6%
120/1035 • Number of events 136
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
5.2%
53/1019 • Number of events 64
|
5.0%
51/1016 • Number of events 63
|
7.0%
72/1035 • Number of events 88
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
26.9%
274/1019 • Number of events 309
|
26.6%
270/1016 • Number of events 305
|
22.5%
233/1035 • Number of events 263
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.1%
52/1019 • Number of events 55
|
5.5%
56/1016 • Number of events 66
|
7.1%
74/1035 • Number of events 105
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
7.1%
72/1019 • Number of events 81
|
5.2%
53/1016 • Number of events 60
|
6.9%
71/1035 • Number of events 81
|
|
Nervous system disorders
DIZZINESS
|
16.9%
172/1019 • Number of events 218
|
15.2%
154/1016 • Number of events 194
|
14.0%
145/1035 • Number of events 171
|
|
Nervous system disorders
DYSGEUSIA
|
7.9%
80/1019 • Number of events 88
|
7.2%
73/1016 • Number of events 76
|
6.4%
66/1035 • Number of events 70
|
|
Nervous system disorders
HEADACHE
|
49.9%
508/1019 • Number of events 646
|
47.8%
486/1016 • Number of events 609
|
42.3%
438/1035 • Number of events 559
|
|
Psychiatric disorders
ANXIETY
|
11.2%
114/1019 • Number of events 142
|
11.5%
117/1016 • Number of events 143
|
10.8%
112/1035 • Number of events 125
|
|
Psychiatric disorders
DEPRESSION
|
25.4%
259/1019 • Number of events 351
|
19.4%
197/1016 • Number of events 263
|
20.8%
215/1035 • Number of events 257
|
|
Psychiatric disorders
INSOMNIA
|
39.4%
401/1019 • Number of events 482
|
38.3%
389/1016 • Number of events 460
|
41.4%
428/1035 • Number of events 500
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.4%
167/1019 • Number of events 202
|
18.0%
183/1016 • Number of events 223
|
20.3%
210/1035 • Number of events 256
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
17.3%
176/1019 • Number of events 200
|
17.0%
173/1016 • Number of events 201
|
16.6%
172/1035 • Number of events 194
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.4%
55/1019 • Number of events 58
|
5.4%
55/1016 • Number of events 59
|
7.2%
75/1035 • Number of events 81
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
6.2%
63/1019 • Number of events 69
|
6.6%
67/1016 • Number of events 73
|
7.3%
76/1035 • Number of events 86
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
22.9%
233/1019 • Number of events 249
|
20.2%
205/1016 • Number of events 211
|
17.0%
176/1035 • Number of events 178
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
12.0%
122/1019 • Number of events 134
|
11.5%
117/1016 • Number of events 125
|
13.2%
137/1035 • Number of events 162
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.0%
163/1019 • Number of events 194
|
13.6%
138/1016 • Number of events 168
|
17.6%
182/1035 • Number of events 222
|
|
Skin and subcutaneous tissue disorders
RASH
|
22.1%
225/1019 • Number of events 289
|
21.9%
223/1016 • Number of events 280
|
28.0%
290/1035 • Number of events 429
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60