Trial Outcomes & Findings for Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer (NCT NCT01780545)
NCT ID: NCT01780545
Last Updated: 2022-07-11
Results Overview
To determine whether docetaxel administered in combination with OGX-427 provides a survival benefit compared to docetaxel alone.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
36 Months
Results posted on
2022-07-11
Participant Flow
Participant milestones
| Measure |
Experimental Arm: Arm A
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
Control Arm: Arm B
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
|
Overall Study
COMPLETED
|
95
|
99
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Experimental Arm: Arm A
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
Control Arm: Arm B
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer
Baseline characteristics by cohort
| Measure |
Experimental Arm: Arm A
n=99 Participants
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
Control Arm: Arm B
n=101 Participants
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 MonthsTo determine whether docetaxel administered in combination with OGX-427 provides a survival benefit compared to docetaxel alone.
Outcome measures
| Measure |
Experimental Arm: Arm A
n=99 Participants
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
Control Arm: Arm B
n=101 Participants
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
|---|---|---|
|
Overall Survival
|
6.4 months
Interval 4.6 to 9.2
|
5.9 months
Interval 4.8 to 7.3
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: 190 participants who intiated protocol treatment were included in the safety population
To compare the safety and toxicity of OGX-427 in combination with docetaxel to that of docetaxel alone. A summary of per-patient maxiumy grade adverse events of any type is included in the Outcome Measure. Full adverse event information will be submitted further in the record.
Outcome measures
| Measure |
Experimental Arm: Arm A
n=94 Participants
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
Control Arm: Arm B
n=96 Participants
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
|---|---|---|
|
Safety and Toxicity of Regimen
Maximum AE Grade: 2
|
11 Participants
|
15 Participants
|
|
Safety and Toxicity of Regimen
Maximum AE Grade: 0
|
0 Participants
|
2 Participants
|
|
Safety and Toxicity of Regimen
Maximum AE Grade: 1
|
6 Participants
|
7 Participants
|
|
Safety and Toxicity of Regimen
Maximum AE Grade: 3
|
40 Participants
|
41 Participants
|
|
Safety and Toxicity of Regimen
Maximum AE Grade: 4
|
32 Participants
|
26 Participants
|
|
Safety and Toxicity of Regimen
Maximum AE Grade: 5
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Every 6 weeksPopulation: Data for this secondary outcome measure was not collected nor analyzed.
To compare overall response rate (ORR) between the treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: Subjects with a baseline Hsp27 level were included in this subgroup analysis
A subgroup analysis to determine the median overall survival time based on baseline Hsp27 levels.
Outcome measures
| Measure |
Experimental Arm: Arm A
n=79 Participants
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
Control Arm: Arm B
n=82 Participants
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
|---|---|---|
|
Overall Survival (OS) According to Baseline Serum Hsp27 Level.
|
9.4 months
Interval 5.8 to 12.4
|
4.7 months
Interval 3.7 to 6.0
|
SECONDARY outcome
Timeframe: Cycle 1Population: Data for this secondary outcome was not collected or analyzed.
To evaluate the association of urothelial carcinoma expression of Hsp27 measured by immunohistochemistry (IHC) in archival tissue with clinical outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to screening, prior to first loading dose, and prior to cycles 1, 2, 3 and 5Population: Data for this secondary objective was not collected or analyzed.
To evaluate the effect of therapy with docetaxel and OGX-427 on peripheral blood circulating tumor cells (CTCs) enumeration and expression of Hsp27 and other relevant proteins via immunoflourescence, and levels of telomerase by quantitative polymerase chain reaction (PCR), and explore their relation with clinical outcomes.
Outcome measures
Outcome data not reported
Adverse Events
Experimental Arm: Arm A
Serious events: 56 serious events
Other events: 94 other events
Deaths: 78 deaths
Control Arm: Arm B
Serious events: 45 serious events
Other events: 93 other events
Deaths: 86 deaths
Serious adverse events
| Measure |
Experimental Arm: Arm A
n=99 participants at risk
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
Control Arm: Arm B
n=101 participants at risk
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
4.0%
4/99 • Number of events 5 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Infections and infestations
APPENDICITIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
ASCITES
|
1.0%
1/99 • Number of events 2 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
BLADDER PERFORATION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
General disorders
CHILLS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
COLITIS
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Investigations
CREATININE INCREASED
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
General disorders
DEATH NOS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.1%
6/99 • Number of events 6 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Psychiatric disorders
DELIRIUM
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
General disorders
FATIGUE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
6.1%
6/99 • Number of events 7 • Duration of study, up to 36 months
|
7.9%
8/101 • Number of events 8 • Duration of study, up to 36 months
|
|
General disorders
FEVER
|
7.1%
7/99 • Number of events 8 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
GASTRIC HEMORRHAGE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
HEMATURIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
ILEUS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Nervous system disorders
INTRACRANIAL HEMORRHAGE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Infections and infestations
LUNG INFECTION
|
2.0%
2/99 • Number of events 3 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
General disorders
MULTI-ORGAN FAILURE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Nervous system disorders
SEIZURE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Infections and infestations
SEPSIS
|
13.1%
13/99 • Number of events 13 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 7 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Nervous system disorders
STROKE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
10.1%
10/99 • Number of events 13 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Vascular disorders
VASCULAR DISORDERS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
VOMITING
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Eye disorders
CATARACT
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
COLONIC FISTULA
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
COLONIC PERFORATION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/99 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
General disorders
EDEMA LIMBS
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Vascular disorders
HEMATOMA
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
General disorders
PAIN
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Cardiac disorders
PERICARDIAL TAMPONADE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Vascular disorders
PERIPHERAL ISCHEMIA
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/99 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Infections and infestations
SMALL INTESTINE INFECTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
Other adverse events
| Measure |
Experimental Arm: Arm A
n=99 participants at risk
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
Control Arm: Arm B
n=101 participants at risk
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
28.3%
28/99 • Number of events 40 • Duration of study, up to 36 months
|
12.9%
13/101 • Number of events 15 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
3.0%
3/99 • Number of events 4 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Nervous system disorders
AKATHISIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
10.1%
10/99 • Number of events 14 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 8 • Duration of study, up to 36 months
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
6.1%
6/99 • Number of events 8 • Duration of study, up to 36 months
|
5.9%
6/101 • Number of events 7 • Duration of study, up to 36 months
|
|
Immune system disorders
ALLERGIC REACTION
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
26.3%
26/99 • Number of events 30 • Duration of study, up to 36 months
|
25.7%
26/101 • Number of events 28 • Duration of study, up to 36 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
38.4%
38/99 • Number of events 88 • Duration of study, up to 36 months
|
35.6%
36/101 • Number of events 77 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
ANOREXIA
|
42.4%
42/99 • Number of events 69 • Duration of study, up to 36 months
|
29.7%
30/101 • Number of events 36 • Duration of study, up to 36 months
|
|
Psychiatric disorders
ANXIETY
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 7 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.1%
9/99 • Number of events 11 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 6 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.1%
6/99 • Number of events 9 • Duration of study, up to 36 months
|
7.9%
8/101 • Number of events 10 • Duration of study, up to 36 months
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.1%
11/99 • Number of events 14 • Duration of study, up to 36 months
|
19.8%
20/101 • Number of events 24 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
BLADDER SPASM
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
BLOATING
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Eye disorders
BLURRED VISION
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 6 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
5.9%
6/101 • Number of events 9 • Duration of study, up to 36 months
|
|
Infections and infestations
BRONCHIAL INFECTION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPULMONARY HEMORRHAGE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Injury, poisoning and procedural complications
BRUISING
|
3.0%
3/99 • Number of events 4 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
BULLOUS DERMATITIS
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
BUTTOCK PAIN
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Cardiac disorders
CARDIAC DISORDERS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Investigations
CD4 LYMPHOCYTES DECREASED
|
1.0%
1/99 • Number of events 3 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 4 • Duration of study, up to 36 months
|
|
General disorders
CHILLS
|
24.2%
24/99 • Number of events 27 • Duration of study, up to 36 months
|
11.9%
12/101 • Number of events 13 • Duration of study, up to 36 months
|
|
Investigations
CHOLESTEROL HIGH
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
3.0%
3/99 • Number of events 6 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Psychiatric disorders
CONFUSION
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Eye disorders
CONJUNCTIVITIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
37.4%
37/99 • Number of events 49 • Duration of study, up to 36 months
|
24.8%
25/101 • Number of events 29 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
18.2%
18/99 • Number of events 32 • Duration of study, up to 36 months
|
14.9%
15/101 • Number of events 17 • Duration of study, up to 36 months
|
|
Investigations
CREATININE INCREASED
|
30.3%
30/99 • Number of events 46 • Duration of study, up to 36 months
|
11.9%
12/101 • Number of events 19 • Duration of study, up to 36 months
|
|
Endocrine disorders
CUSHINGOID
|
1.0%
1/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Immune system disorders
CYTOKINE RELEASE SYNDROME
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
15.2%
15/99 • Number of events 15 • Duration of study, up to 36 months
|
9.9%
10/101 • Number of events 10 • Duration of study, up to 36 months
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Psychiatric disorders
DEPRESSION
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
DIARRHEA
|
47.5%
47/99 • Number of events 72 • Duration of study, up to 36 months
|
34.7%
35/101 • Number of events 60 • Duration of study, up to 36 months
|
|
Nervous system disorders
DIZZINESS
|
14.1%
14/99 • Number of events 14 • Duration of study, up to 36 months
|
10.9%
11/101 • Number of events 11 • Duration of study, up to 36 months
|
|
Eye disorders
DRY EYE
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
DRY MOUTH
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
11.1%
11/99 • Number of events 11 • Duration of study, up to 36 months
|
9.9%
10/101 • Number of events 10 • Duration of study, up to 36 months
|
|
Nervous system disorders
DYSGEUSIA
|
17.2%
17/99 • Number of events 22 • Duration of study, up to 36 months
|
16.8%
17/101 • Number of events 20 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.1%
5/99 • Number of events 5 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
DYSPHAGIA
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
28.3%
28/99 • Number of events 35 • Duration of study, up to 36 months
|
28.7%
29/101 • Number of events 35 • Duration of study, up to 36 months
|
|
Ear and labyrinth disorders
EAR AND LABYRINTH DISORDERS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
General disorders
EDEMA FACE
|
2.0%
2/99 • Number of events 3 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 3 • Duration of study, up to 36 months
|
|
General disorders
EDEMA LIMBS
|
21.2%
21/99 • Number of events 33 • Duration of study, up to 36 months
|
24.8%
25/101 • Number of events 41 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
8.1%
8/99 • Number of events 9 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 6 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
ERYTHRODERMA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Eye disorders
EYE DISORDERS
|
4.0%
4/99 • Number of events 7 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 8 • Duration of study, up to 36 months
|
|
Eye disorders
EYE PAIN
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
General disorders
FACIAL PAIN
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Injury, poisoning and procedural complications
FALL
|
5.1%
5/99 • Number of events 5 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 8 • Duration of study, up to 36 months
|
|
General disorders
FATIGUE
|
63.6%
63/99 • Number of events 119 • Duration of study, up to 36 months
|
65.3%
66/101 • Number of events 128 • Duration of study, up to 36 months
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
General disorders
FEVER
|
28.3%
28/99 • Number of events 36 • Duration of study, up to 36 months
|
13.9%
14/101 • Number of events 19 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
9.1%
9/99 • Number of events 10 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
FLATULENCE
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
General disorders
FLU LIKE SYMPTOMS
|
6.1%
6/99 • Number of events 6 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Vascular disorders
FLUSHING
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
General disorders
GAIT DISTURBANCE
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
GASTRITIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
5.1%
5/99 • Number of events 5 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
12.1%
12/99 • Number of events 17 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 7 • Duration of study, up to 36 months
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
|
5.1%
5/99 • Number of events 17 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
17.2%
17/99 • Number of events 22 • Duration of study, up to 36 months
|
16.8%
17/101 • Number of events 21 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
GENITAL EDEMA
|
4.0%
4/99 • Number of events 6 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Eye disorders
GLAUCOMA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
GLUCOSE INTOLERANCE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Psychiatric disorders
HALLUCINATIONS
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Nervous system disorders
HEADACHE
|
11.1%
11/99 • Number of events 16 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 12 • Duration of study, up to 36 months
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Vascular disorders
HEMATOMA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
HEMATURIA
|
9.1%
9/99 • Number of events 11 • Duration of study, up to 36 months
|
9.9%
10/101 • Number of events 12 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
5.9%
6/101 • Number of events 7 • Duration of study, up to 36 months
|
|
Vascular disorders
HOT FLASHES
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
4.0%
4/99 • Number of events 7 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 11 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
18.2%
18/99 • Number of events 45 • Duration of study, up to 36 months
|
13.9%
14/101 • Number of events 22 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
7.1%
7/99 • Number of events 16 • Duration of study, up to 36 months
|
5.9%
6/101 • Number of events 8 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Vascular disorders
HYPERTENSION
|
12.1%
12/99 • Number of events 18 • Duration of study, up to 36 months
|
12.9%
13/101 • Number of events 15 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
3.0%
3/99 • Number of events 9 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
14.1%
14/99 • Number of events 27 • Duration of study, up to 36 months
|
14.9%
15/101 • Number of events 21 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
8.1%
8/99 • Number of events 11 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 12 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
9.1%
9/99 • Number of events 15 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
6.1%
6/99 • Number of events 6 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
23.2%
23/99 • Number of events 32 • Duration of study, up to 36 months
|
10.9%
11/101 • Number of events 16 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
12.1%
12/99 • Number of events 18 • Duration of study, up to 36 months
|
11.9%
12/101 • Number of events 19 • Duration of study, up to 36 months
|
|
Vascular disorders
HYPOTENSION
|
8.1%
8/99 • Number of events 11 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 8 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
7.1%
7/99 • Number of events 13 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 5 • Duration of study, up to 36 months
|
|
General disorders
INFUSION RELATED REACTION
|
7.1%
7/99 • Number of events 9 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Investigations
INR INCREASED
|
7.1%
7/99 • Number of events 13 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Psychiatric disorders
INSOMNIA
|
11.1%
11/99 • Number of events 12 • Duration of study, up to 36 months
|
18.8%
19/101 • Number of events 24 • Duration of study, up to 36 months
|
|
Injury, poisoning and procedural complications
INTRAOPERATIVE MUSCULOSKELETAL INJURY
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
1.0%
1/99 • Number of events 3 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Nervous system disorders
LETHARGY
|
1.0%
1/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
2.0%
2/99 • Number of events 3 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 4 • Duration of study, up to 36 months
|
|
General disorders
LOCALIZED EDEMA
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
17.2%
17/99 • Number of events 58 • Duration of study, up to 36 months
|
10.9%
11/101 • Number of events 34 • Duration of study, up to 36 months
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
1.0%
1/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
General disorders
MALAISE
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Metabolism and nutrition disorders
METABOLISM AND NUTRITION DISORDERS
|
3.0%
3/99 • Number of events 5 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Infections and infestations
MUCOSAL INFECTION
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
15.2%
15/99 • Number of events 26 • Duration of study, up to 36 months
|
20.8%
21/101 • Number of events 26 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
5.1%
5/99 • Number of events 6 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS RIGHT-SIDED
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER
|
11.1%
11/99 • Number of events 16 • Duration of study, up to 36 months
|
5.9%
6/101 • Number of events 6 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.1%
6/99 • Number of events 8 • Duration of study, up to 36 months
|
5.9%
6/101 • Number of events 12 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
NAIL DISCOLORATION
|
7.1%
7/99 • Number of events 10 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 7 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
NAIL RIDGING
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
7.1%
7/99 • Number of events 10 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
NAUSEA
|
41.4%
41/99 • Number of events 63 • Duration of study, up to 36 months
|
33.7%
34/101 • Number of events 49 • Duration of study, up to 36 months
|
|
General disorders
NECK EDEMA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
35.4%
35/99 • Number of events 58 • Duration of study, up to 36 months
|
32.7%
33/101 • Number of events 46 • Duration of study, up to 36 months
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
7.1%
7/99 • Number of events 7 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
ORAL DYSESTHESIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
ORAL PAIN
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Infections and infestations
OTITIS EXTERNA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
General disorders
PAIN
|
19.2%
19/99 • Number of events 27 • Duration of study, up to 36 months
|
19.8%
20/101 • Number of events 27 • Duration of study, up to 36 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
14.1%
14/99 • Number of events 27 • Duration of study, up to 36 months
|
15.8%
16/101 • Number of events 23 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Nervous system disorders
PARESTHESIA
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 7 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
1.0%
1/99 • Number of events 3 • Duration of study, up to 36 months
|
5.9%
6/101 • Number of events 8 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
PENILE PAIN
|
2.0%
2/99 • Number of events 3 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
PERINEAL PAIN
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
3.0%
3/99 • Number of events 4 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 9 • Duration of study, up to 36 months
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
28.3%
28/99 • Number of events 46 • Duration of study, up to 36 months
|
21.8%
22/101 • Number of events 28 • Duration of study, up to 36 months
|
|
Vascular disorders
PHLEBITIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Eye disorders
PHOTOPHOBIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Investigations
PLATELET COUNT DECREASED
|
12.1%
12/99 • Number of events 16 • Duration of study, up to 36 months
|
9.9%
10/101 • Number of events 13 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE HEMORRHAGE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Nervous system disorders
PRESYNCOPE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
PROTEINURIA
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
11.1%
11/99 • Number of events 19 • Duration of study, up to 36 months
|
7.9%
8/101 • Number of events 10 • Duration of study, up to 36 months
|
|
Psychiatric disorders
PSYCHIATRIC DISORDERS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
13.1%
13/99 • Number of events 22 • Duration of study, up to 36 months
|
7.9%
8/101 • Number of events 9 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS
|
7.1%
7/99 • Number of events 11 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 14 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 6 • Duration of study, up to 36 months
|
|
Psychiatric disorders
RESTLESSNESS
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Infections and infestations
RHINITIS INFECTIVE
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
SCALP PAIN
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Nervous system disorders
SEIZURE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Infections and infestations
SEPSIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
SINUS DISORDER
|
1.0%
1/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
8.1%
8/99 • Number of events 9 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 6 • Duration of study, up to 36 months
|
|
Infections and infestations
SINUSITIS
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
13.1%
13/99 • Number of events 25 • Duration of study, up to 36 months
|
6.9%
7/101 • Number of events 12 • Duration of study, up to 36 months
|
|
Infections and infestations
SKIN INFECTION
|
3.0%
3/99 • Number of events 3 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
4.0%
4/99 • Number of events 6 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 5 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
STOMACH PAIN
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Nervous system disorders
SYNCOPE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
7.1%
7/99 • Number of events 7 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 7 • Duration of study, up to 36 months
|
|
Ear and labyrinth disorders
TINNITUS
|
4.0%
4/99 • Number of events 4 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOR PAIN
|
3.0%
3/99 • Number of events 4 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
2.0%
2/99 • Number of events 3 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
8.1%
8/99 • Number of events 9 • Duration of study, up to 36 months
|
11.9%
12/101 • Number of events 13 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
5.1%
5/99 • Number of events 8 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
15.2%
15/99 • Number of events 28 • Duration of study, up to 36 months
|
10.9%
11/101 • Number of events 12 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
2.0%
2/99 • Number of events 2 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
URINARY URGENCY
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
VOMITING
|
20.2%
20/99 • Number of events 23 • Duration of study, up to 36 months
|
15.8%
16/101 • Number of events 27 • Duration of study, up to 36 months
|
|
Eye disorders
WATERING EYES
|
4.0%
4/99 • Number of events 6 • Duration of study, up to 36 months
|
5.0%
5/101 • Number of events 6 • Duration of study, up to 36 months
|
|
Investigations
WEIGHT GAIN
|
2.0%
2/99 • Number of events 4 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Investigations
WEIGHT LOSS
|
13.1%
13/99 • Number of events 17 • Duration of study, up to 36 months
|
14.9%
15/101 • Number of events 18 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
31.3%
31/99 • Number of events 54 • Duration of study, up to 36 months
|
22.8%
23/101 • Number of events 35 • Duration of study, up to 36 months
|
|
Infections and infestations
WOUND INFECTION
|
1.0%
1/99 • Number of events 1 • Duration of study, up to 36 months
|
0.00%
0/101 • Duration of study, up to 36 months
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
0.00%
0/99 • Duration of study, up to 36 months
|
4.0%
4/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
APNEA
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Infections and infestations
BLADDER INFECTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Nervous system disorders
CONCENTRATION IMPAIRMENT
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/99 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
General disorders
EDEMA TRUNK
|
0.00%
0/99 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 3 • Duration of study, up to 36 months
|
|
Endocrine disorders
ENDOCRINE DISORDERS - OTHER, SPECIFY
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Eye disorders
FLASHING LIGHTS
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Investigations
HEMOGLOBIN INCREASED
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Blood and lymphatic system disorders
HEMOLYTIC UREMIC SYNDROME
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/99 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL HEMORRHAGE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL MUCOSITIS
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Infections and infestations
LIP INFECTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
LIP PAIN
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HEMORRHAGE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Vascular disorders
LYMPHEDEMA
|
0.00%
0/99 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
NAIL LOSS
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
ORAL HEMORRHAGE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Eye disorders
PAPILLEDEMA
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/99 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
RECTAL FISTULA
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Gastrointestinal disorders
RECTAL PAIN
|
0.00%
0/99 • Duration of study, up to 36 months
|
3.0%
3/101 • Number of events 4 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
SCROTAL PAIN
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Nervous system disorders
TREMOR
|
0.00%
0/99 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/99 • Duration of study, up to 36 months
|
2.0%
2/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Renal and urinary disorders
URINE DISCOLORATION
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Investigations
URINE OUTPUT DECREASED
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Reproductive system and breast disorders
VAGINAL HEMORRHAGE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 6 • Duration of study, up to 36 months
|
|
Vascular disorders
VASCULAR DISORDERS - OTHER, SPECIFY
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
|
Eye disorders
VITREOUS HEMORRHAGE
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 2 • Duration of study, up to 36 months
|
|
Cardiac disorders
WOLFF-PARKINSON-WHITE SYNDROME
|
0.00%
0/99 • Duration of study, up to 36 months
|
0.99%
1/101 • Number of events 1 • Duration of study, up to 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place