Trial Outcomes & Findings for A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00138658)
NCT ID: NCT00138658
Last Updated: 2012-02-06
Results Overview
Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR). The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles. CR: disappearance of clinical/radiological evidence of tumor. PR: \>= 30% decrease in the sum of the longest diameter of target lesions. SD: did not fulfill the criteria for CR or PR but not progressive disease.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.
Results posted on
2012-02-06
Participant Flow
Participants were recruited at 15 institutions with a primary focus on oncology and located in the United States and Canada. The date of the first screening visit was November 2004 and the last survival followup was February 2010.
Four subjects who were assigned a study ID number were determined to be ineligible (i.e., failed one or more inclusion/exclusion criteria) and were never treated.
Participant milestones
| Measure |
OGX-011 - Intent to Treat Analysis Set
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
OGX-011 - Intent to Treat Analysis Set
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
|
Overall Study
Adverse Event
|
23
|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease Progression
|
21
|
|
Overall Study
Physician Decision
|
11
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=81 Participants
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Age Continuous
|
60.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Baseline ECOG
ECOG O
|
26 participants
n=5 Participants
|
|
Baseline ECOG
ECOG 1
|
54 participants
n=5 Participants
|
|
Baseline ECOG
ECOG 2
|
1 participants
n=5 Participants
|
|
Cancer Stage
Stage IIIB
|
15 participants
n=5 Participants
|
|
Cancer Stage
Stage IV
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.Population: The efficacy analysis included all 81 subjects that received at least one dose of OGX-011. Of the 25 subjects with CR or PR, 21 subjects had a confirmed response. The other 4 patients did not have confirmatory scans (n=3) or discontinued treatment (N=1).
Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR). The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles. CR: disappearance of clinical/radiological evidence of tumor. PR: \>= 30% decrease in the sum of the longest diameter of target lesions. SD: did not fulfill the criteria for CR or PR but not progressive disease.
Outcome measures
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=81 Participants
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
|
Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen
|
26 percentage of participants
|
SECONDARY outcome
Timeframe: All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.Population: Number of patients who progressed or died (n=75); data for 6 patients were censored. (PFS was censored at the date of the first dose of OGX-011 for subjects who failed to return for any disease assessments after screening.)
Progression-free survival (PFS) was defined as time from first treatment with OGX-011 to documented evidence of disease progression or date of death. For subjects without disease progression based on RECIST who initiated subsequent anti-cancer therapy, date of progression was defined as date of initiating new cancer treatment. PFS was censored as of the date of first OGX-011 dose for subjects who failed to return for assessments after screening. For subjects who were still alive and without progressive disease at the time of data cut-off, PFS was censored at date of last disease assessment.
Outcome measures
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=75 Participants
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
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Progression-free Survival
|
4.3 months
Interval 3.0 to 5.3
|
SECONDARY outcome
Timeframe: All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.Population: Number of subjects who died (n=70); n=11 subjects were censored at end of study (10 were alive and 1 was lost to follow up)
Overall survival was defined as time from date of first treatment with OGX-011 to the date of death from any cause. Overall survival was censored at date of last contact for subjects who were still alive at end of study.
Outcome measures
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=70 Participants
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
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Overall Survival
|
14.1 months
Interval 9.4 to 17.5
|
SECONDARY outcome
Timeframe: Blood samples were collected at baseline and prior to infusion on Cycle 2 Day 1 and Cycle 3 Day 1Population: 55 evaluable subjects had baseline value and at least one post-baseline serum clusterin assessment.
To measure the effect of OGX-011 on serum clusterin levels. The drug substance, OGX-011, is an antisense product designed to bind to clusterin mRNA, resulting in the inhibition of the production of human clusterin protein. Therefore, serum clusterin levels were expected to decrease.
Outcome measures
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=55 Participants
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
|
Effect of OGX-011 on Serum Clusterin Levels
|
-25.5 µg/mL
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.Population: Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011
Cmax is a plasma pharmacokinetic parameter that is defined as the maximum observed concentration of drug substance in plasma.
Outcome measures
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=6 Participants
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
|
Cmax of OGX-011
|
64086 ng/mL
Standard Deviation 8756
|
SECONDARY outcome
Timeframe: Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.Population: Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011
Plasma half life of OGX-011
Outcome measures
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=6 Participants
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
|
t1/2 of OGX-011
|
3.7 hours
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.Population: Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011
AUC-0-last is the area under the plasma concentration time curve from time 0 to the last last time point (23.5 hrs)
Outcome measures
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=6 Participants
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
|
AUC-0-last
|
260747 ng*h/mL
Standard Deviation 42578
|
Adverse Events
OGX-011 - Intent to Treat Analysis Set
Serious events: 32 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=81 participants at risk
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
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|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.4%
6/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
2/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Chills
|
2.5%
2/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Oedema peripheral
|
2.5%
2/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Pyrexia
|
2.5%
2/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Fatigue
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Pain
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Infections and infestations
Bacteraemia
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Infections and infestations
Folliculitis
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Infections and infestations
Pneumonia bacterial
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Infections and infestations
Sepsis
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Infections and infestations
Wound infection
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.7%
3/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Ataxia
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Motor dysfunction
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
2/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Cardiac disorders
Ventricular hypokinesia
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Gastric perforation
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Psychiatric disorders
Confusional state
|
2.5%
2/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Vascular disorders
Hypotension
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Blood creatinine increased
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Eye disorders
Blindness cortical
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
Other adverse events
| Measure |
OGX-011 - Intent to Treat Analysis Set
n=81 participants at risk
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
44.4%
36/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.4%
36/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.9%
25/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
9/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Nausea
|
74.1%
60/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Vomiting
|
59.3%
48/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Fatigue
|
70.4%
57/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Chills
|
63.0%
51/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Pyrexia
|
61.7%
50/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Oedema Peripheral
|
30.9%
25/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Chest Pain
|
19.8%
16/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Pain
|
18.5%
15/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Asthenia
|
17.3%
14/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Influenza Like Illness
|
8.6%
7/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
General disorders
Chest Discomfort
|
7.4%
6/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Constipation
|
58.0%
47/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Diarrhoea
|
34.6%
28/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.6%
11/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Stomatitis
|
9.9%
8/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
9/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.9%
8/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Dry Mouth
|
7.4%
6/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Gastrointestinal disorders
Dysphagia
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
53.1%
43/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.2%
18/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
21.0%
17/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.3%
10/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.9%
8/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Dysgeusia
|
37.0%
30/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Headache
|
35.8%
29/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Dizziness
|
29.6%
24/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.9%
8/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Paraesthesia
|
8.6%
7/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Tremor
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Nervous system disorders
Neuropathy Peripheral
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.7%
33/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.9%
21/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.3%
14/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.4%
6/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
7.4%
6/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
34.6%
28/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.9%
21/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.6%
11/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.0%
17/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
17.3%
14/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.8%
12/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
11.1%
9/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
11.1%
9/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.6%
7/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Weight Decreased
|
17.3%
14/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Blood Creatinine Increased
|
16.0%
13/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Creatinine Renal Clearance Decreased
|
13.6%
11/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Alanine Aminotransferase Increased
|
12.3%
10/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
12.3%
10/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Aspartate Aminotransferase Increased
|
11.1%
9/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Haemoglobin Decreased
|
9.9%
8/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Investigations
Platelet Count Decreased
|
7.4%
6/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Psychiatric disorders
Insomnia
|
33.3%
27/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Psychiatric disorders
Anxiety
|
21.0%
17/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Psychiatric disorders
Confusional State
|
7.4%
6/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Psychiatric disorders
Depression
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Infections and infestations
Oral Candidiasis
|
9.9%
8/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Infections and infestations
Oral Herpes
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Infections and infestations
Urinary Tract Infection
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Vascular disorders
Phlebitis
|
9.9%
8/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Vascular disorders
Hypotension
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Vascular disorders
Flushing
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Vascular disorders
Hot Flush
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Vascular disorders
Hypertension
|
6.2%
5/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Ear and labyrinth disorders
Tinnitus
|
18.5%
15/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.6%
7/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Eye disorders
Vision Blurred
|
4.9%
4/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
|
Cardiac disorders
Tachycardia
|
7.4%
6/81 • Displays of adverse events include treatment-emergent events in all subjects who had at least one adverse event with onset on or after the date of administration of the first dose of study treatment through 30 days after the last dose of study treatment.
Adverse events are systematically assessed through regular investigator assessment and laboratory testing that is clearly defined in the protocol.
|
Additional Information
Dr. Patricia Stewart, Vice President Medical Affairs
OncoGenex Pharmaceuticals
Phone: 425-686-1500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review proposed written or oral material which describes the results of the Study prior to public release and can embargo communications for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The results from one institution shall not be presented before the multi-center publication. If there is no multi-center publication within 12 months after the Study completion the Investigator shall have the right to publish the results.
- Publication restrictions are in place
Restriction type: OTHER