Trial Outcomes & Findings for A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer (NCT NCT00637247)
NCT ID: NCT00637247
Last Updated: 2019-03-20
Results Overview
To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
up to 2 years
Results posted on
2019-03-20
Participant Flow
Recruitment period was from April 2008 to May 2009. Enrollment occurred at 34 clinical centers in the United States.
Participant milestones
| Measure |
Amplimexon (Imexon) + Gemcitabine
Amplimexon 875 mg/m\^2 + gemcitabine 1000 mg/m\^2
|
Imexon Placebo + Gemcitabine
Placebo 875 mg/m\^2+ gemcitabine 1000 mg/m\^2
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
70
|
|
Overall Study
COMPLETED
|
72
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Amplimexon (Imexon) + Gemcitabine
n=72 Participants
Amplimexon 875 mg/m\^2 + gemcitabine 1000 mg/m\^2
|
Imexon Placebo + Gemcitabine
n=70 Participants
Placebo 875 mg/m\^2+ gemcitabine 1000 mg/m\^2
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
64.9 years
STANDARD_DEVIATION 11.1 • n=107 Participants
|
65.5 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=99 Participants
|
70 participants
n=107 Participants
|
142 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: Intention to treat with subjects who were alive at the time of the survival analysis or lost to follow-up were considered censored at the last date the subject was known to be alive.
To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.
Outcome measures
| Measure |
Amplimexon (Imexon) + Gemcitabine
n=72 Participants
Amplimexon 875 mg/m\^2 + gemcitabine 1000 mg/m\^2
|
Imexon Placebo + Gemcitabine
n=70 Participants
Placebo 875 mg/m\^2+ gemcitabine 1000 mg/m\^2
|
|---|---|---|
|
Overall Survival for the Intent to Treat Population
|
5.2 months
Interval 4.2 to 6.7
|
6.8 months
Interval 4.9 to 8.5
|
PRIMARY outcome
Timeframe: Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 monthsPopulation: This includes only those subjects that received at least 1 dose of study treatment. There were 67 subjects in the imexon + gemcitabine arm and 68 in the placebo + gemcitabine arm.
Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events
Outcome measures
| Measure |
Amplimexon (Imexon) + Gemcitabine
n=67 Participants
Amplimexon 875 mg/m\^2 + gemcitabine 1000 mg/m\^2
|
Imexon Placebo + Gemcitabine
n=68 Participants
Placebo 875 mg/m\^2+ gemcitabine 1000 mg/m\^2
|
|---|---|---|
|
To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events
|
67 participants
|
68 participants
|
SECONDARY outcome
Timeframe: one yearPopulation: Per protocol, response evaluable population was treated and had baseline and at least one response evaluation.
Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.
Outcome measures
| Measure |
Amplimexon (Imexon) + Gemcitabine
n=53 Participants
Amplimexon 875 mg/m\^2 + gemcitabine 1000 mg/m\^2
|
Imexon Placebo + Gemcitabine
n=55 Participants
Placebo 875 mg/m\^2+ gemcitabine 1000 mg/m\^2
|
|---|---|---|
|
Objective Response Rates of the Two Treatment Arms
|
13.2 percent of responses
|
16.4 percent of responses
|
SECONDARY outcome
Timeframe: one yearPopulation: Intention to treat
To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
Outcome measures
| Measure |
Amplimexon (Imexon) + Gemcitabine
n=72 Participants
Amplimexon 875 mg/m\^2 + gemcitabine 1000 mg/m\^2
|
Imexon Placebo + Gemcitabine
n=70 Participants
Placebo 875 mg/m\^2+ gemcitabine 1000 mg/m\^2
|
|---|---|---|
|
Progression Free Survival
|
2.8 months
Interval 2.0 to 4.1
|
3.8 months
Interval 2.2 to 4.7
|
Adverse Events
Amplimexon (Imexon) + Gemcitabine
Serious events: 51 serious events
Other events: 66 other events
Deaths: 0 deaths
Imexon Placebo + Gemcitabine
Serious events: 44 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amplimexon (Imexon) + Gemcitabine
n=67 participants at risk
Amplimexon 875 mg/m\^2 + gemcitabine 1000 mg/m\^2
|
Imexon Placebo + Gemcitabine
n=68 participants at risk
Placebo 875 mg/m\^2+ gemcitabine 1000 mg/m\^2
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Blood and lymphatic system disorders
Hemoglobin (low)
|
3.0%
2/67 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Blood and lymphatic system disorders
Neutrophils (low)
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Cardiac disorders
Conduction abnormality-AV block-third degree
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Cardiac disorders
Supraventricular arrhythmia-atrial fibrillation
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Cardiac disorders
Supraventricular arrhythmia-atrial flutter
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Vascular disorders
Hypertension
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Fatigue
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Fever
|
10.4%
7/67 • Number of events 7 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Death-death not otherwise specified
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
5.9%
4/68 • Number of events 4 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Death-disease progression not otherwise specified
|
22.4%
15/67 • Number of events 15 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
16.2%
11/68 • Number of events 11 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
2/67 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
3/67 • Number of events 3 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Distension
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
2/67 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Gastrointestinal (GI) other-gastrostromy (G) tube leak
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Obstruction-small bowel not otherwise specified
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Hepatobiliary disorders
Stricture-biliary tree
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
2/67 • Number of events 3 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Hemorrhage-abdomen not otherwise specified
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Hemorrhage-duodenum
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Hemorrhage- lower gastrointestinal not otherwise specified
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage-nose
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Hemorrhage-other gastrointestinal
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Hemorrhage-upper gastrointestinal not otherwise specified
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Hepatobiliary disorders
Hepatobiliary-other-biliary obstruction
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Hepatobiliary disorders
Liver dysfunction
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
4.4%
3/68 • Number of events 3 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Blood and lymphatic system disorders
Fever-neutropenic
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Infections and infestations
Infection with normal absolute neutrophil count-biliary tree
|
3.0%
2/67 • Number of events 3 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Infections and infestations
Infection with normal absolute neutrophil count-blood
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Infections and infestations
Infection with normal absolute neutrophil count-lung (pneumonia)
|
7.5%
5/67 • Number of events 5 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
5.9%
4/68 • Number of events 5 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Infections and infestations
Infection with normal absolute neutrophil count-cellulitis
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Infections and infestations
Infection with unknown absolute neutrophil count-lung (pneumonia)
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Edema:trunk/genital
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness-whole body/generalized
|
3.0%
2/67 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Nervous system disorders
Central nervous system ischemia
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Psychiatric disorders
Confusion
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Nervous system disorders
Syncope (fainting)
|
3.0%
2/67 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Pain-abdomen not otherwise specified
|
6.0%
4/67 • Number of events 4 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
5.9%
4/68 • Number of events 4 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Musculoskeletal and connective tissue disorders
Pain-back
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Pain-chest/thorax not otherwise specified
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Pain-pain not otherwise specified
|
3.0%
2/67 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Pain-stomach
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
2/67 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
5.9%
4/68 • Number of events 4 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Renal and urinary disorders
Renal-other-hemolytic uremic syndrome
|
1.5%
1/67 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
0.00%
0/68 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Vascular disorders
Peripheral arterial ischemia
|
0.00%
0/67 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
7.5%
5/67 • Number of events 5 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
7.4%
5/68 • Number of events 5 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
Other adverse events
| Measure |
Amplimexon (Imexon) + Gemcitabine
n=67 participants at risk
Amplimexon 875 mg/m\^2 + gemcitabine 1000 mg/m\^2
|
Imexon Placebo + Gemcitabine
n=68 participants at risk
Placebo 875 mg/m\^2+ gemcitabine 1000 mg/m\^2
|
|---|---|---|
|
Investigations
Platelets (low)
|
41.8%
28/67 • Number of events 100 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
47.1%
32/68 • Number of events 102 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Blood and lymphatic system disorders
Hemoglobin (low)
|
50.7%
34/67 • Number of events 84 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
52.9%
36/68 • Number of events 89 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Investigations
Neutrophils (low)
|
26.9%
18/67 • Number of events 55 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
47.1%
32/68 • Number of events 109 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Fatigue
|
65.7%
44/67 • Number of events 75 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
64.7%
44/68 • Number of events 84 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Investigations
Leukocytes (low)
|
34.3%
23/67 • Number of events 84 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
25.0%
17/68 • Number of events 51 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Pain-abdomen not otherwise specified
|
49.3%
33/67 • Number of events 50 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
48.5%
33/68 • Number of events 61 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Nausea
|
62.7%
42/67 • Number of events 64 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
42.6%
29/68 • Number of events 44 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Investigations
ALT (high)
|
26.9%
18/67 • Number of events 49 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
23.5%
16/68 • Number of events 36 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Fever
|
40.3%
27/67 • Number of events 49 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
26.5%
18/68 • Number of events 24 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Investigations
AST (high)
|
26.9%
18/67 • Number of events 38 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
20.6%
14/68 • Number of events 34 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Constipation
|
46.3%
31/67 • Number of events 41 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
38.2%
26/68 • Number of events 30 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Vomiting
|
37.3%
25/67 • Number of events 34 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
35.3%
24/68 • Number of events 37 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Edema:limb
|
34.3%
23/67 • Number of events 31 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
39.7%
27/68 • Number of events 38 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Investigations
Lymphopenia
|
14.9%
10/67 • Number of events 35 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
16.2%
11/68 • Number of events 27 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
34.3%
23/67 • Number of events 29 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
38.2%
26/68 • Number of events 30 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Gastrointestinal disorders
Diarrhea
|
31.3%
21/67 • Number of events 23 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
32.4%
22/68 • Number of events 36 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.8%
22/67 • Number of events 28 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
29.4%
20/68 • Number of events 29 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Investigations
Alkaline phosphatase (high)
|
19.4%
13/67 • Number of events 21 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
27.9%
19/68 • Number of events 31 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.9%
10/67 • Number of events 18 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
19.1%
13/68 • Number of events 31 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.0%
4/67 • Number of events 13 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
20.6%
14/68 • Number of events 26 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.4%
13/67 • Number of events 18 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
16.2%
11/68 • Number of events 13 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Musculoskeletal and connective tissue disorders
Pain-extremity-limb
|
10.4%
7/67 • Number of events 12 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
16.2%
11/68 • Number of events 19 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.9%
12/67 • Number of events 18 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
14.7%
10/68 • Number of events 13 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
17.9%
12/67 • Number of events 12 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
26.5%
18/68 • Number of events 19 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
|
General disorders
Rigors/chills
|
23.9%
16/67 • Number of events 17 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
14.7%
10/68 • Number of events 12 • Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The manuscript or abstract shall be submitted at least (45) days prior to submission for publication to permit Sponsor to request removal of any Confidential Information and to protect its rights to any patentable inventions set forth therein. Upon Sponsor's reasonable request, the investigator shall redact Sponsor's Confidential Information from any such proposed publication or shall delay publication for up to 90 days to permit Sponsor to protect its proprietary Information.
- Publication restrictions are in place
Restriction type: OTHER