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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Dose Comparison, Parallel Assignment |
| Condition: |
Hepatitis C, Chronic |
| Interventions: |
Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908) Biological: PEGASYS (peginterferon alfa-2a) Drug: COPEGUS (ribavirin) |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Enrolled 4469 subjects; Randomized 3083; Treated 3070 |
| Description | |
|---|---|
| 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 |
| PegIntron 1.5 ug/kg/wk Plus REBETOL | PegIntron 1.0 ug/kg/wk Plus REBETOL | PEGASYS 180 ug/wk Plus COPEGUS | |
|---|---|---|---|
| STARTED | 1019 | 1016 | 1035 |
| COMPLETED | 517[1] | 470[2] | 579[3] |
| NOT COMPLETED | 502 | 546 | 456 |
| Adverse Event | 130 | 98 | 136 |
| Lack of Efficacy | 262 | 357 | 211 |
| Lost to Follow-up | 45 | 34 | 45 |
| Protocol Violation | 15 | 10 | 10 |
| Withdrawal by Subject | 45 | 40 | 42 |
| Did not meet protocol eligibility | 2 | 0 | 3 |
| Administrative | 1 | 0 | 1 |
| Not Specified | 2 | 7 | 8 |
| [1] | Patients who discontinued treatment but continued in study are considered Not Completed |
|---|---|
| [2] | Patients who discontinued treatment but continued in study are considered Not Completed |
| [3] | Patients who discontinued treatment but continued in study are considered Not Completed |
Baseline Characteristics
| Description | |
|---|---|
| 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 |
| PegIntron 1.5 ug/kg/wk Plus REBETOL | PegIntron 1.0 ug/kg/wk Plus REBETOL | PEGASYS 180 ug/wk Plus COPEGUS | Total | |
|---|---|---|---|---|
|
Number of Participants [units: participants] |
1019 | 1016 | 1035 | 3070 |
|
Age [units: years] Mean ± Standard Deviation |
47.5 ± 7.8 | 47.5 ± 8.1 | 47.6 ± 8.2 | 47.5 ± 8.0 |
|
Gender [units: participants] |
||||
| Female | 406 | 409 | 422 | 1237 |
| Male | 613 | 607 | 613 | 1833 |
Outcome Measures
| 1. Primary: | Sustained Virologic Response (SVR) Rate [ Assessed at the end of a 24-week post-treatment follow-up ] |
| 2. Secondary: | Mean Change From Baseline in the Log Viral Load at Treatment Week 4 [ Assessed at Baseline and Treatment Week 4 ] |
| 3. Secondary: | Virologic Response Rate at Treatment Week 12 [ Assessed at Treatment Week 12 ] |
| 4. Secondary: | Mean Change From Baseline in the Log Viral Load at Treatment Week 2 [ Assessed at Baseline and Treatment Week 2 ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
| Description | |
|---|---|
| PegIntron 1.5 ug/kg/wk Plus REBETOL | No text entered. |
| PegIntron 1.0 ug/kg/wk Plus REBETOL | No text entered. |
| PEGASYS 180 ug/wk Plus COPEGUS | No text entered. |
| PegIntron 1.5 ug/kg/wk Plus REBETOL | PegIntron 1.0 ug/kg/wk Plus REBETOL | PEGASYS 180 ug/wk Plus COPEGUS | |
|---|---|---|---|
| Total, serious adverse events | |||
| # participants affected / at risk | 88/1019 (8.64%) | 94/1016 (9.25%) | 121/1035 (11.69%) |
| Blood and lymphatic system disorders | |||
| ANAEMIA † A # participants affected / at risk # events |
3/1019 (0.29%) 3 |
3/1016 (0.30%) 3 |
1/1035 (0.10%) 1 |
| APLASTIC ANAEMIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| DISSEMINATED INTRAVASCULAR COAGULATION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| HAEMOLYTIC ANAEMIA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| LEUKOPENIA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| LYMPHADENITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| LYMPHADENOPATHY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| NEUTROPENIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| PANCYTOPENIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| THROMBOCYTOPENIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
2/1035 (0.19%) 2 |
| THROMBOTIC THROMBOCYTOPENIC PURPURA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| Cardiac disorders | |||
| ACUTE MYOCARDIAL INFARCTION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ATRIAL FIBRILLATION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ATRIAL TACHYCARDIA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| ATRIOVENTRICULAR BLOCK COMPLETE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| CARDIAC FAILURE CONGESTIVE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CARDIO-RESPIRATORY ARREST † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CARDIOMYOPATHY † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| CORONARY ARTERY DISEASE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CORONARY ARTERY RESTENOSIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| CORONARY ARTERY STENOSIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CYANOSIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| MYOCARDIAL INFARCTION † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
2/1016 (0.20%) 2 |
2/1035 (0.19%) 2 |
| PALPITATIONS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| PERICARDITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
2/1016 (0.20%) 2 |
0/1035 (0.00%) 0 |
| VENTRICULAR FIBRILLATION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| WOLFF-PARKINSON-WHITE SYNDROME † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| Ear and labyrinth disorders | |||
| HEARING IMPAIRED † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| VERTIGO † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| Endocrine disorders | |||
| ADRENAL INSUFFICIENCY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| HYPOTHYROIDISM † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| Eye disorders | |||
| CATARACT † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 2 |
| MACULOPATHY † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| PAPILLOEDEMA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| RETINAL DETACHMENT † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| RETINAL HAEMORRHAGE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| Gastrointestinal disorders | |||
| ABDOMINAL HERNIA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| ABDOMINAL PAIN † A # participants affected / at risk # events |
2/1019 (0.20%) 3 |
4/1016 (0.39%) 5 |
4/1035 (0.39%) 4 |
| APPENDICITIS PERFORATED † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| COLITIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| COLITIS ISCHAEMIC † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| DIARRHOEA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| EROSIVE OESOPHAGITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| FOOD POISONING † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| GASTRIC ULCER † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| GASTRITIS EROSIVE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| GASTROINTESTINAL PAIN † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| GASTROOESOPHAGEAL REFLUX DISEASE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| HAEMATEMESIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HAEMORRHOIDAL HAEMORRHAGE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HAEMORRHOIDS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ILEUS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| INGUINAL HERNIA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
2/1016 (0.20%) 2 |
0/1035 (0.00%) 0 |
| IRRITABLE BOWEL SYNDROME † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| LARGE INTESTINAL OBSTRUCTION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| MALLORY-WEISS SYNDROME † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| NAUSEA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
5/1035 (0.48%) 5 |
| OESOPHAGEAL VARICES HAEMORRHAGE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| PANCREATIC CYST † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| PANCREATIC ENLARGEMENT † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| PANCREATIC MASS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| PANCREATITIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
2/1016 (0.20%) 2 |
0/1035 (0.00%) 0 |
| PANCREATITIS ACUTE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| PERITONEAL HAEMORRHAGE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| RECTAL HAEMORRHAGE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| SALIVARY DUCT OBSTRUCTION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| SMALL INTESTINAL OBSTRUCTION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| VOMITING † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
3/1016 (0.30%) 3 |
4/1035 (0.39%) 4 |
| General disorders | |||
| CHEST DISCOMFORT † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
2/1016 (0.20%) 2 |
3/1035 (0.29%) 3 |
| CHEST PAIN † A # participants affected / at risk # events |
8/1019 (0.79%) 8 |
8/1016 (0.79%) 8 |
8/1035 (0.77%) 8 |
| DEATH † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| DRUG WITHDRAWAL SYNDROME † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| FACE OEDEMA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| FATIGUE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HERNIA OBSTRUCTIVE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| NON-CARDIAC CHEST PAIN † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
2/1016 (0.20%) 2 |
1/1035 (0.10%) 1 |
| PYREXIA † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
2/1016 (0.20%) 2 |
0/1035 (0.00%) 0 |
| Hepatobiliary disorders | |||
| BILE DUCT STENOSIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| BILE DUCT STONE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| BILIARY DYSKINESIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CHOLECYSTITIS † A # participants affected / at risk # events |
3/1019 (0.29%) 3 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| CHOLECYSTITIS ACUTE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| CHOLECYSTITIS CHRONIC † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| CHOLELITHIASIS † A # participants affected / at risk # events |
5/1019 (0.49%) 5 |
3/1016 (0.30%) 3 |
3/1035 (0.29%) 3 |
| JAUNDICE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 2 |
| PORTAL HYPERTENSIVE GASTROPATHY † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| Immune system disorders | |||
| HYPERSENSITIVITY † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| SARCOIDOSIS † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
1/1016 (0.10%) 1 |
3/1035 (0.29%) 3 |
| Infections and infestations | |||
| ABDOMINAL WALL INFECTION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ABSCESS LIMB † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| ANOGENITAL WARTS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| APPENDICITIS † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
4/1016 (0.39%) 4 |
4/1035 (0.39%) 5 |
| BLASTOMYCOSIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| BRONCHITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| BURSITIS INFECTIVE STAPHYLOCOCCAL † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CELLULITIS † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
5/1016 (0.49%) 5 |
6/1035 (0.58%) 6 |
| CHOLECYSTITIS INFECTIVE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| DIVERTICULITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| ENCEPHALITIS VIRAL † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| ENTEROCOLITIS INFECTIOUS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ESCHERICHIA SEPSIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| FOLLICULITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| GASTROENTERITIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| GASTROENTERITIS VIRAL † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| HERPES OESOPHAGITIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| INFECTION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| INFECTIVE TENOSYNOVITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| INJECTION SITE ABSCESS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| INJECTION SITE CELLULITIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| KIDNEY INFECTION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| LOBAR PNEUMONIA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| LUNG ABSCESS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| MENINGITIS VIRAL † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ORCHITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| PERITONEAL ABSCESS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
2/1035 (0.19%) 2 |
| PNEUMONIA † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
3/1016 (0.30%) 3 |
6/1035 (0.58%) 6 |
| PNEUMONIA STREPTOCOCCAL † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
3/1035 (0.29%) 3 |
| PYELONEPHRITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
2/1016 (0.20%) 2 |
1/1035 (0.10%) 1 |
| SEPSIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| SEPSIS SYNDROME † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| SINUSITIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| STAPHYLOCOCCAL ABSCESS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| STAPHYLOCOCCAL INFECTION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
2/1035 (0.19%) 2 |
| STAPHYLOCOCCAL SKIN INFECTION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| SUBCUTANEOUS ABSCESS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| URINARY TRACT INFECTION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| VIRAL INFECTION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| WOUND INFECTION STAPHYLOCOCCAL † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| Injury, poisoning and procedural complications | |||
| ACCIDENTAL OVERDOSE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| ALCOHOL POISONING † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ANIMAL BITE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| ARTHROPOD BITE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| BACK INJURY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| CERVICAL VERTEBRAL FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| CLAVICLE FRACTURE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| CONCUSSION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| DRUG TOXICITY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| FACIAL BONES FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 2 |
0/1035 (0.00%) 0 |
| FALL † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
3/1016 (0.30%) 3 |
0/1035 (0.00%) 0 |
| FEMUR FRACTURE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| GUN SHOT WOUND † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HAND FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| HEAD INJURY † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HEPATIC HAEMATOMA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HIP FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| HUMAN BITE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| JAW FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 3 |
0/1035 (0.00%) 0 |
| LUNG INJURY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| MUSCLE STRAIN † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| OVERDOSE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
2/1016 (0.20%) 2 |
2/1035 (0.19%) 2 |
| PELVIC FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| POST PROCEDURAL BILE LEAK † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| POST PROCEDURAL HAEMATOMA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| RIB FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 2 |
0/1035 (0.00%) 0 |
| ROAD TRAFFIC ACCIDENT † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
3/1016 (0.30%) 3 |
1/1035 (0.10%) 1 |
| SCAPULA FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| SKIN LACERATION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| SPINAL FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| SPLENIC RUPTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| THERAPEUTIC AGENT TOXICITY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| THERMAL BURN † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| TOOTH FRACTURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| TRAUMATIC BRAIN INJURY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| WRIST FRACTURE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| Investigations | |||
| ELECTROCARDIOGRAM ST SEGMENT DEPRESSION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| GRIP STRENGTH DECREASED † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| LIVER FUNCTION TEST ABNORMAL † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| WHITE BLOOD CELL COUNT DECREASED † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| Metabolism and nutrition disorders | |||
| DEHYDRATION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
2/1016 (0.20%) 2 |
3/1035 (0.29%) 3 |
| DIABETES MELLITUS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
2/1035 (0.19%) 2 |
| DIABETIC KETOACIDOSIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| HYPERCALCAEMIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| HYPERGLYCAEMIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
2/1016 (0.20%) 2 |
0/1035 (0.00%) 0 |
| HYPONATRAEMIA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HYPOVOLAEMIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| TYPE 2 DIABETES MELLITUS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| Musculoskeletal and connective tissue disorders | |||
| ARTHRALGIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| BACK PAIN † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| BURSITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| GOUTY ARTHRITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| INTERVERTEBRAL DISC PROTRUSION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| JOINT INSTABILITY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| MUSCULOSKELETAL CHEST PAIN † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| MUSCULOSKELETAL PAIN † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| NECK PAIN † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| OSTEOARTHRITIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| PAIN IN EXTREMITY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 2 |
| RHABDOMYOLYSIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| SPINAL OSTEOARTHRITIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| WEIGHT BEARING DIFFICULTY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | |||
| ACOUSTIC NEUROMA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ACUTE MYELOID LEUKAEMIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| BLADDER NEOPLASM † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| BREAST CANCER † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
2/1035 (0.19%) 2 |
| HAEMANGIOMA OF LIVER † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| HEPATIC NEOPLASM MALIGNANT † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
2/1035 (0.19%) 2 |
| LUNG NEOPLASM † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| MALIGNANT MELANOMA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| MALIGNANT NEOPLASM OF AMPULLA OF VATER † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| METASTASES TO LIVER † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| OROPHARYNGEAL CANCER STAGE UNSPECIFIED † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| OVARIAN ADENOMA † A # participants affected / at risk # events |
1/1019 (0.10%) 2 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| PANCREATIC CARCINOMA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| UTERINE LEIOMYOMA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| Nervous system disorders | |||
| AKATHISIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ANOXIC ENCEPHALOPATHY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CEREBRAL HAEMORRHAGE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CEREBROVASCULAR ACCIDENT † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| COMA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CONVULSION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
2/1035 (0.19%) 2 |
| DIZZINESS † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
2/1016 (0.20%) 2 |
0/1035 (0.00%) 0 |
| DYSARTHRIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ENCEPHALOPATHY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| FACIAL PALSY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| HYPOAESTHESIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 2 |
| INTRACRANIAL ANEURYSM † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 2 |
0/1035 (0.00%) 0 |
| LOSS OF CONSCIOUSNESS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| MIGRAINE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| NEUROPATHY PERIPHERAL † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| PARAESTHESIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 2 |
1/1035 (0.10%) 1 |
| PARAPLEGIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| PERONEAL NERVE PALSY † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| PRESYNCOPE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| SCIATICA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| SPINAL CORD COMPRESSION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| SPINAL CORD INFARCTION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 2 |
| SYNCOPE † A # participants affected / at risk # events |
4/1019 (0.39%) 4 |
1/1016 (0.10%) 1 |
3/1035 (0.29%) 3 |
| SYNCOPE VASOVAGAL † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| Pregnancy, puerperium and perinatal conditions | |||
| ABORTION SPONTANEOUS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
3/1016 (0.30%) 3 |
0/1035 (0.00%) 0 |
| Psychiatric disorders | |||
| ACUTE PSYCHOSIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| AFFECTIVE DISORDER † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| AGITATION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| ANGER † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| ANXIETY † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
2/1016 (0.20%) 2 |
1/1035 (0.10%) 1 |
| COMPLETED SUICIDE † A # participants affected / at risk # events |
3/1019 (0.29%) 3 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| DEPENDENCE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| DEPRESSION † A # participants affected / at risk # events |
5/1019 (0.49%) 9 |
3/1016 (0.30%) 3 |
3/1035 (0.29%) 3 |
| DISORIENTATION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| DRUG ABUSE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
2/1035 (0.19%) 2 |
| DRUG DEPENDENCE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| HALLUCINATION † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HALLUCINATION, AUDITORY † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HALLUCINATION, VISUAL † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| HOMICIDAL IDEATION † A # participants affected / at risk # events |
2/1019 (0.20%) 3 |
2/1016 (0.20%) 2 |
0/1035 (0.00%) 0 |
| MENTAL STATUS CHANGES † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| PARANOIA † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| PSYCHOTIC DISORDER † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| SUICIDAL IDEATION † A # participants affected / at risk # events |
13/1019 (1.28%) 17 |
8/1016 (0.79%) 8 |
5/1035 (0.48%) 5 |
| SUICIDE ATTEMPT † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
2/1035 (0.19%) 2 |
| Renal and urinary disorders | |||
| BLADDER DISORDER † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| CALCULUS URETERIC † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| NEPHROLITHIASIS † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| NEPHROTIC SYNDROME † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| RENAL FAILURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| RENAL FAILURE ACUTE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| RENAL PAIN † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| URINARY INCONTINENCE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| Reproductive system and breast disorders | |||
| CERVICAL DYSPLASIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| CYSTOCELE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| RECTOCELE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| UTERINE HAEMORRHAGE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| VAGINAL HAEMORRHAGE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| VAGINAL PROLAPSE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| Respiratory, thoracic and mediastinal disorders | |||
| ACUTE RESPIRATORY DISTRESS SYNDROME † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ACUTE RESPIRATORY FAILURE † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ASTHMA † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
2/1016 (0.20%) 2 |
2/1035 (0.19%) 3 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| DYSPNOEA † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
5/1016 (0.49%) 5 |
3/1035 (0.29%) 3 |
| EPISTAXIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| HYPOXIA † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| PLEURISY † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| PNEUMONIA ASPIRATION † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| PULMONARY EMBOLISM † A # participants affected / at risk # events |
2/1019 (0.20%) 2 |
0/1016 (0.00%) 0 |
3/1035 (0.29%) 3 |
| PULMONARY HYPERTENSION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| PULMONARY SARCOIDOSIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| Skin and subcutaneous tissue disorders | |||
| ERYTHEMA MULTIFORME † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| Social circumstances | |||
| PHYSICAL ASSAULT † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
0/1035 (0.00%) 0 |
| Surgical and medical procedures | |||
| CYSTOPEXY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| HYSTERECTOMY † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| RECTOCELE REPAIR † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| SALPINGO-OOPHORECTOMY UNILATERAL † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| SPINAL FUSION SURGERY † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| Vascular disorders | |||
| DEEP VEIN THROMBOSIS † A # participants affected / at risk # events |
0/1019 (0.00%) 0 |
1/1016 (0.10%) 1 |
1/1035 (0.10%) 1 |
| HYPERTENSION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| HYPOTENSION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
1/1035 (0.10%) 1 |
| ORTHOSTATIC HYPOTENSION † A # participants affected / at risk # events |
1/1019 (0.10%) 1 |
0/1016 (0.00%) 0 |
0/1035 (0.00%) 0 |
| † | Indicates events were collected by systematic assessment. |
|---|---|
| A | Term from vocabulary, MedDRA 10.1 |
Other Adverse Events
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P03471, 2552898 |
| Study First Received: | April 20, 2004 |
| Results First Received: | November 3, 2008 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00081770 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
