Trial Outcomes & Findings for Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (NCT NCT00729053)
NCT ID: NCT00729053
Last Updated: 2018-06-12
Results Overview
Best overall objective (i.e., radiological) response by RECIST v1.0 for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
From start of treatment every 8 weeks (every 2 cycles), 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.
Results posted on
2018-06-12
Participant Flow
Participant milestones
| Measure |
Previous Treatment, 0.16mg/kg
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Previous Treatment, 0.64mg/kg
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.16mg/kg
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.64mg/kg
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
23
|
23
|
|
Overall Study
COMPLETED
|
23
|
23
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Baseline characteristics by cohort
| Measure |
Previous Treatment, 0.16mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Previous Treatment, 0.64mg/kg
n=21 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.16mg/kg
n=22 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.64mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
59.2 Years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
65.6 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
60.6 Years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
61.4 Years
STANDARD_DEVIATION 10.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From start of treatment every 8 weeks (every 2 cycles), 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.Population: ITT Population
Best overall objective (i.e., radiological) response by RECIST v1.0 for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.
Outcome measures
| Measure |
Previous Treatment, 0.16mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Previous Treatment, 0.64mg/kg
n=21 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.16mg/kg
n=22 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.64mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
|---|---|---|---|---|
|
Best Response by RECIST v1.0
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of treatment through one month after the end of study visit (up to 28 weeks)Population: Safety Population
Number of patients with Treatment-emergent adverse events (TEAEs) by National Cancer Institute (NCI) grade/severity that began on or after the date of the first injection of study drug or worsened in severity or frequency after study drug was administered.
Outcome measures
| Measure |
Previous Treatment, 0.16mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Previous Treatment, 0.64mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.16mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.64mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity
Patients with at least 1 TEAE
|
23 Participants
|
23 Participants
|
21 Participants
|
22 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity
Patients with at least 1 serious TEAE
|
6 Participants
|
10 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity
Patients with a TEAE related to treatment
|
21 Participants
|
22 Participants
|
16 Participants
|
19 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity
Patients with at least 1 severe (Grade+) TEAE
|
9 Participants
|
14 Participants
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Every 8 weeks (2 cycles) from first response to documented disease progression during treatment, 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.Population: Participants with reported response as reflected in Outcome Measure 1
Time in days from the date of the first response by RECIST v1.0 to documented disease progression or death from any cause.
Outcome measures
| Measure |
Previous Treatment, 0.16mg/kg
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Previous Treatment, 0.64mg/kg
n=1 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.16mg/kg
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.64mg/kg
n=1 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
|---|---|---|---|---|
|
Duration of Response by RECIST v1.0
|
—
|
179 Days
|
—
|
52 Days
|
SECONDARY outcome
Timeframe: From date of randomization until the date of progression or date of death from any cause, whichever came first, asses up to 1 year after the last dose of study drug.Population: ITT Population
Overall survival is defined as (date of death +1 - date of randomization). Patients without an event (death) during treatment or follow-up will have their date censored on the last visit the patient was known to be alive.
Outcome measures
| Measure |
Previous Treatment, 0.16mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Previous Treatment, 0.64mg/kg
n=21 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.16mg/kg
n=22 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.64mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
|---|---|---|---|---|
|
Overall Survival at 1 Year
|
15 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progressionPopulation: ITT Population
Time between the date of randomization to the Study Day of documented disease progression (an increase in tumor burden of at least 20%, appearance of new lesions, or unequivocal progression of non-measurable disease) or death (whichever comes first) by RECIST v1.0. Patients who had not progressed at last disease assessment, but whose progression status was unknown at the date last known alive, date of death, or date of study exit (whichever comes first), had event time censored at the date of last assessment. Patients who did not die and did not progress during treatment or follow-up had their event time censored on the last contact date.
Outcome measures
| Measure |
Previous Treatment, 0.16mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Previous Treatment, 0.64mg/kg
n=21 Participants
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.16mg/kg
n=22 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.64mg/kg
n=23 Participants
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
|---|---|---|---|---|
|
Time to Disease Progression.
|
103.0 Days
Interval 56.0 to 123.0
|
131.0 Days
Interval 60.0 to 178.0
|
138.5 Days
Interval 108.0 to 217.0
|
59.0 Days
Interval 53.0 to 123.0
|
Adverse Events
Previous Treatment, 0.16mg/kg
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Previous Treatment, 0.64mg/kg
Serious events: 10 serious events
Other events: 23 other events
Deaths: 1 deaths
Treatment Naive, 0.16mg/kg
Serious events: 5 serious events
Other events: 21 other events
Deaths: 1 deaths
Treatment Naive, 0.64mg/kg
Serious events: 8 serious events
Other events: 22 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Previous Treatment, 0.16mg/kg
n=23 participants at risk
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Previous Treatment, 0.64mg/kg
n=23 participants at risk
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.16mg/kg
n=23 participants at risk
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.64mg/kg
n=23 participants at risk
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
General disorders
Adverse drug reaction
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
General disorders
Chills
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
General disorders
Chest pains
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
General disorders
Injection site reaction
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
General disorders
Pyrexia
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Cardiac disorders
Hypertenisve heart disease
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Infections and infestations
Abdomen wall abcess
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Renal and urinary disorders
Renal failure, acute
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Investigations
Anticoagulant above therapeutic range
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
0.00%
0/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
Other adverse events
| Measure |
Previous Treatment, 0.16mg/kg
n=23 participants at risk
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Previous Treatment, 0.64mg/kg
n=23 participants at risk
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.16mg/kg
n=23 participants at risk
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
Treatment Naive, 0.64mg/kg
n=23 participants at risk
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055: immunostimulatory oligonucleotide
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
60.9%
14/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
56.5%
13/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
47.8%
11/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
39.1%
9/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Gastrointestinal disorders
Nausea
|
60.9%
14/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
52.2%
12/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
26.1%
6/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
43.5%
10/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
General disorders
Chills
|
34.8%
8/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
69.6%
16/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
30.4%
7/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
43.5%
10/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Nervous system disorders
Headache
|
43.5%
10/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
30.4%
7/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
39.1%
9/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
34.8%
8/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
General disorders
Pyrexia
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
56.5%
13/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
21.7%
5/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
39.1%
9/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Gastrointestinal disorders
Vomiting
|
30.4%
7/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
30.4%
7/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
30.4%
7/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.7%
5/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
26.1%
6/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
21.7%
5/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
21.7%
5/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Gastrointestinal disorders
Constipation
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
26.1%
6/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
34.8%
8/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Gastrointestinal disorders
Diarrhea
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
30.4%
7/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Metabolism and nutrition disorders
Anorexia
|
21.7%
5/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
26.1%
6/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Blood and lymphatic system disorders
Anemia
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
21.7%
5/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
26.1%
6/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
26.1%
6/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
26.1%
6/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
21.7%
5/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
21.7%
5/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
General disorders
Peripheral edema
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
4.3%
1/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
17.4%
4/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
|
Psychiatric disorders
Insomnia
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
13.0%
3/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
8.7%
2/23 • From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER